Femara

(Letrozole)

ApprovedSmall molecule

Letrozole is used to treat hormone receptor-positive breast cancer in postmenopausal women. It works by lowering estrogen levels in the body, which helps slow or stop the growth of breast cancer cells that depend on estrogen.[2] Femara is currently approved and in use across 56 indications[4].[1]

Femara is one of 572 small molecule programs targeting Hyperplasia. It is currently in Approved.

Indications

529

Total Trials

Active Trials

571

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HyperplasiaActive, not recruiting

Gestational Trophoblastic NeoplasmApproved

Uterine LeiomyosarcomaRecruiting

MetastasisApproved

Paroxysmal Familial Ventricular FibrillationApproved

AdenomyosisApproved

LeiomyosarcomaApproved

Hypogonadotropic HypogonadismApproved

Estrogen-Receptor Positive Breast CancerCompleted

Follicular CystApproved

HyperplasiaPhase 3

Active, not recruiting

Gestational Trophoblastic NeoplasmApproved

Approved

Uterine LeiomyosarcomaPhase 2

Recruiting

MetastasisApproved

Approved

Paroxysmal Familial Ventricular FibrillationApproved

Approved

AdenomyosisApproved

Approved

LeiomyosarcomaApproved

Approved

Hypogonadotropic HypogonadismApproved

Approved

Estrogen-Receptor Positive Breast CancerApproved

Completed

Follicular CystApproved

Approved

Showing 10 of 56 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Femara

Adenocard

2 3

Lexiscan

Astellas

Preclinical

1 4

Voltaren

Novartis

Preclinical

1 5

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 6

Duragesic-100

CCephalon

Preclinical

2 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 8

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 9

Tricor

JJagotec

Preclinical

1 10

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Breast Cancer

NCT02712723

Phase 3Active, not recruiting

Breast Cancer

NCT05909397

Phase 2Active, not recruiting

Endometrial Cancer

NCT04393285

Phase 2Active, not recruiting

Ovarian Cancer

NCT03673124

Q2 2027

N/ARecruiting

Ovarian Cyst

NCT05487092

Q3 2027

Phase 2/3Active, not recruiting

Hyperplasia

NCT06390904

Clinical

Trials by Indication[1]

Breast Cancer109 trials

Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT01698918·202 enrolled

Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer

Completed·UUniversity of Alabama at Birmingham·Phase 1/2·NCT02520063·15 enrolled

Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT05909397·59 enrolled

Show 106 more trials

Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer

Completed·WWashington University School of Medicine·Phase 2·NCT03007979·55 enrolled

Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.

Completed· Novartis logo

Novartis·Phase 1·NCT02154776·13 enrolled

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05514054·8,000 enrolled

Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Hormone Therapy

Completed·UUniversity of Washington·N/A·NCT01720602·15 enrolled

Panobinostat and Letrozole in Treating Patients With Metastatic Breast Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 1/2·NCT01105312·28 enrolled

Safety and Efficacy of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT01231659·72 enrolled

Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-Sensitive Metastatic Breast Cancer

Terminated·VVanderbilt-Ingram Cancer Center·Phase 2·NCT01205685·11 enrolled

Everolimus trIal for Advanced prememopausaL Breast Cancer Patients

Unknown status·CChinese Academy of Medical Sciences·Phase 2·NCT02313051·200 enrolled

Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer

Recruiting·KKarolinska University Hospital·Phase 2·NCT05900206·370 enrolled

Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

Completed·—·Phase 2·NCT00903162·17 enrolled

Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00265759·622 enrolled

Breast Cancer & Antiestrogenic Therapy & Brain

Not yet recruiting·IInternational Research Training Group 2804··NCT06346457·180 enrolled

Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy

Active, not recruiting· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 2·NCT06957379·78 enrolled

Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)

Terminated·EErasme University Hospital·Phase 4·NCT04289805·96 enrolled

Addition of Aromatase at the Navelbine in Pretreated Metastatic Breast Cancer.

Terminated·AARCAGY/ GINECO GROUP·Phase 2·NCT02585388·120 enrolled

Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer

Terminated·JJonsson Comprehensive Cancer Center·Phase 1·NCT03128619·10 enrolled

Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

Completed·IIntarcia Therapeutics·Phase 3·NCT00044291·865 enrolled

Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer

Active, not recruiting·NNSABP Foundation Inc·Phase 3·NCT00382070·3,966 enrolled

Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer

Completed·RRutgers, The State University of New Jersey·Phase 1/2·NCT00634634·52 enrolled

A Study for Safety and Effectiveness of IMC-A12 by Itself or Combined With Antiestrogens to Treat Breast Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00728949·93 enrolled

Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer

Terminated· Novartis logo

Novartis·Phase 4·NCT00171847·93 enrolled

Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT00247663·17 enrolled

Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01068704·4 enrolled

BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00708214·28 enrolled

Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate

Completed· Pfizer logo

Pfizer·Phase 3·NCT02600923·131 enrolled

PTK and Letrozole in Post-menopausal Women With Advanced Breast Cancer

Terminated·WWashington University School of Medicine·Phase 2·NCT00263198·4 enrolled

Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

No longer available· Pfizer logo

Pfizer··NCT02142868

Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer

Unknown status·SShengjing Hospital·Phase 3·NCT04047758·420 enrolled

NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer

Unknown status·MMidwestern Regional Medical Center·Phase 2·NCT02689921·7 enrolled

Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT02291913·48 enrolled

A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Treatment With Focus on Mechanisms of Resistance to Endocrine Treatment (Fulvestrant/Aromatase Inhibitors) in Patients With Advanced Breast Cancer

Completed·LLund University Hospital·Phase 2·NCT02958852·126 enrolled

Pre-Operative Study of PF-4691502 With Letrozole Compared To Letrozole Alone In Patients With Early Breast Cancer

Terminated· Pfizer logo

Pfizer·Phase 2·NCT01430585·14 enrolled

Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer

Completed·GGBG Forschungs GmbH·Phase 2·NCT03555877·56 enrolled

NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer - VALENTINE Trial

Active, not recruiting·SSOLTI Breast Cancer Research Group·Phase 2·NCT05569811·120 enrolled

Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00880009·16 enrolled

Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice

Recruiting· Novartis logo

Novartis··NCT06905301·240 enrolled

RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF

Completed·WWeill Medical College of Cornell University·Phase 4·NCT01035099·41 enrolled

Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer

Terminated· Pfizer logo

Pfizer·Phase 3·NCT00083993·1,236 enrolled

A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)

Terminated· Novartis logo

Novartis·Phase 2·NCT01919229·14 enrolled

Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT00516542·6 enrolled

Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer

Completed·EETOP IBCSG Partners Foundation·Phase 3·NCT00004205·8,028 enrolled

Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04256941·4 enrolled

Neoadjuvant Run-In Study With TAK-228 Followed by Letrozole/TAK-228 in Women With High-Risk ER+/HER2- Breast Cancer

Withdrawn·GGary Schwartz·Phase 1·NCT02619669

HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.

Unknown status·NNational Cancer Institute, Naples·Phase 3·NCT00412022·1,294 enrolled

A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer

Recruiting·BBeta Pharma (Suzhou) Co., Ltd.·Phase 1/2·NCT04282031·224 enrolled

A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib

Terminated· Novartis logo

Novartis·Phase 3·NCT03050398·8 enrolled

Safety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00329940·200 enrolled

Letrozole and Lapatinib Followed by Everolimus in Women With Advanced Breast Cancer

Terminated·UUniversity of Maryland, Baltimore·Phase 2·NCT01499160·7 enrolled

Safety and Efficacy of Hormone Therapy With Letrozole in Postmenopausal Women With Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00330317·300 enrolled

ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06570031·46 enrolled

Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

Terminated·UUniversity of Medicine and Dentistry of New Jersey·Phase 2·NCT00101062

Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy

Completed·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University··NCT04258163·760 enrolled

Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

Completed· Pfizer logo

Pfizer·Phase 2·NCT00721409·177 enrolled

Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer

Completed·MMedSIR·Phase 2·NCT02491983·486 enrolled

Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer

Terminated·IIntarcia Therapeutics·Phase 3·NCT00267553·200 enrolled

Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer

Recruiting·SShengjing Hospital·Phase 2·NCT05638594·236 enrolled

Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer

Active, not recruiting·UUniversity of Chicago·Phase 2·NCT03879577·53 enrolled

Effects of Adjuvant Endocrine Therapy With Aromatase Inhibitors on the Postoperative Lipid Levels in Postmenopausal Breast Cancer Patients

Unknown status·CChinese Academy of Medical Sciences··NCT02765373·500 enrolled

A Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

Terminated·—·Phase 3·NCT02730091·98 enrolled

Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer

Active, not recruiting·QQamar Khan·Phase 2·NCT02712723·121 enrolled

Chemotherapy and Hormone Therapy as First-Line Therapy in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer

Withdrawn·TTechnical University of Munich·Phase 3·NCT00403182

Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00332852·655 enrolled

A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer

Completed· Roche logo

Roche·Phase 1·NCT00960960·71 enrolled

A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer

Terminated· Roche logo

Roche·Phase 2·NCT00796107·6 enrolled

Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer

Unknown status·—·Phase 2·NCT00280930·60 enrolled

Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer

Enrolling by invitation·PPeking University·Phase 2·NCT06650748·100 enrolled

Presurgical Treatment With Letrozole in Patients With Early-stage Breast Cancer.

Completed·—·N/A·NCT02010021·17 enrolled

Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients

Active, not recruiting·SSpanish Breast Cancer Research Group·Phase 2·NCT04293393·200 enrolled

Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

Completed· Novartis logo

Novartis·Phase 4·NCT00014638

Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy

Completed· Novartis logo

Novartis·Phase 3·NCT00050011·602 enrolled

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

Completed· Novartis logo

Novartis·Phase 2·NCT03056755·383 enrolled

Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

Completed· Novartis logo

Novartis·Phase 3·NCT00171340·1,065 enrolled

A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer

Completed·VVanderbilt-Ingram Cancer Center·Phase 1·NCT03962647·31 enrolled

A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer

Unknown status·JJinming Yu·Phase 2·NCT04095390·60 enrolled

Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone

Terminated·TTranslational Research in Oncology·Phase 2·NCT02115048·44 enrolled

Phase 0 Study of Metronomic Oral Vinorelbine and Letrozole in HR+/HER2-negative Early Breast Cancer Patients (VENTANA)

Completed·SSOLTI Breast Cancer Research Group·Phase 1·NCT02802748·60 enrolled

A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]

Completed· Pfizer logo

Pfizer·Phase 3·NCT02297438·340 enrolled

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery

Recruiting·UUniversity of Chicago·Phase 2·NCT06348134·74 enrolled

Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women

Completed· Novartis logo

Novartis·Phase 4·NCT00237133·112 enrolled

Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients

Active, not recruiting·RRenJi Hospital·Phase 2/3·NCT02221999·250 enrolled

A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer

Recruiting·RRoyal Marsden NHS Foundation Trust·Phase 2·NCT04985266·1,100 enrolled

Assessing the Response Rate of Neo-adjuvant Paclitaxel (Taxol) in Nigerian Women With Breast Cancer

Withdrawn·UUniversity of Chicago·Phase 2·NCT03058939

Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

Completed· Pfizer logo

Pfizer·Phase 4·NCT02679755·252 enrolled

A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer

Withdrawn·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT04872608

BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT01870505·52 enrolled

Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00696072·120 enrolled

A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)

Completed· Roche logo

Roche·Phase 2·NCT02273973·334 enrolled

Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer

Withdrawn·FFred Hutchinson Cancer Center·Phase 4·NCT03238703

A Window of Opportunity Study of Pre-operative Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Breast Hormone Receptor Positive (HR+) Human Epidermal Receptor 2 Negative (HER2-) Breast Cancer.

Unknown status·SSt Vincent's Hospital·Phase 2·NCT03906669·200 enrolled

Fulvestrant With or Without Lapatinib and/or Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer That Progressed After Previous Aromatase Inhibitor Therapy

Unknown status·GGruppo Italiano Mammella (GIM)·Phase 3·NCT00688194·396 enrolled

Letrozole in Breast Cancer Who Have Received 5 Years of Aromatase Inhibitor Therapy

Completed·CCanadian Cancer Trials Group·Phase 3·NCT00754845·1,918 enrolled

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

Completed· Pfizer logo

Pfizer·Phase 3·NCT01740427·666 enrolled

Neoadjuvant Letrozole in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative, Node Positive, Early-Stage Breast Cancer.

Not yet recruiting·—·Phase 2·NCT07394946·126 enrolled

The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

Terminated·IIntarcia Therapeutics·Phase 3·NCT00097344·842 enrolled

Letrozole in Preventing Breast Cancer in Postmenopausal Women

Completed·—·Phase 2·NCT00090857·49 enrolled

Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT03822468·376 enrolled

Radiological and Biological Tumoural and Peri-tumoural Factors in Neoadjuvant Endocrine-treated Breast Cancers

Completed·NNHS Tayside·N/A·NCT02701348·31 enrolled

Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer

Completed·IInstitut du Cancer de Montpellier - Val d'Aurelle·Phase 3·NCT00949598·177 enrolled

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

Terminated· Sanofi logo

Sanofi·Phase 2·NCT04059484·367 enrolled

Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy

Completed· Novartis logo

Novartis·Phase 2/3·NCT00333047·24 enrolled

Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer

Unknown status·HHaihe Biopharma Co., Ltd.·Phase 1·NCT04856371·228 enrolled

A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Terminated· Roche logo

Roche·Phase 1·NCT01296555·674 enrolled

PhIb BKM120 or BEZ235+Endocrine Treatment in Post-Menopausal Patients With Hormone Receptor + Metastatic Breast Cancer

Completed·VVanderbilt-Ingram Cancer Center·Phase 1·NCT01248494·72 enrolled

Letrozole and Goserelin or Leuprolide in Treating Premenopausal Estrogen Receptor-Positive Patients With Stage IV Breast Cancer

Terminated·UUniversity of Washington·Phase 2·NCT00498901·1 enrolled

Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by Surgery

Terminated·VVanderbilt-Ingram Cancer Center·Phase 1·NCT00651976·213 enrolled

Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy

Terminated·PPalleos Healthcare GmbH·Phase 4·NCT03220178·532 enrolled

Endometrial Cancer5 trials

Letrozole in Treating Women With Recurrent or Metastatic Endometrial Cancer

Completed·NNCIC Clinical Trials Group·Phase 2·NCT00004251·33 enrolled

Abemaciclib and Letrozole to Treat Endometrial Cancer

Active, not recruiting·GGynecologic Oncology Group·Phase 2·NCT04393285·53 enrolled

Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer

Completed·GGOG Foundation·Phase 2·NCT02228681·74 enrolled

Show 2 more trials

A Study of Letrozole in the Treatment of Endometrial Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT00333086·36 enrolled

Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer

Completed·MMayo Clinic·Phase 2·NCT02657928·40 enrolled

Ovulation Induction5 trials

Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS

Completed·—·N/A·NCT03181919·90 enrolled

Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Poly Cystic Ovary Syndrome ( PCOS )

Unknown status·Mmostafa gomaa hamid halawa·Phase 2·NCT02551367·110 enrolled

Comparison Between Two Ovulation Induction Therapies and LOD on Clinical Outcomes in CC-Resistant PCOS Women

Completed·—·Phase 3·NCT06486870·183 enrolled

Show 2 more trials

Administration of Single High Dose Letrozole for Ovulation Induction

Completed·MMount Sinai Hospital, Canada·Phase 4·NCT02703649·36 enrolled

Letrozole Versus Clomifene Citrate for Ovulation Induction

Completed·UUniversity of Nottingham·Phase 4·NCT00478504·159 enrolled

Polycystic Ovary Syndrome5 trials

Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome

Unknown status·—·Phase 3·NCT03009838·150 enrolled

Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine

Unknown status·HHeilongjiang University of Chinese Medicine·N/A·NCT01116167·660 enrolled

Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)

Unknown status·HHeilongjiang University of Chinese Medicine·N/A·NCT01431352·420 enrolled

Show 2 more trials

Pregnancy in Polycystic Ovary Syndrome II

Completed·YYale University·Phase 3·NCT00719186·750 enrolled

Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS)

Withdrawn·CCRG UZ Brussel·Phase 4·NCT04002635

Pregnancy5 trials

Sequential Letrozole and Methotrexate Therapy Role in Treatment of Tubal Ectopic Pregnancy

Completed·ZZagazig University·N/A·NCT06426979·200 enrolled

Comparison of the Effectiveness of Single-Dose Methotrexate Protocol With Letrozole + Single-Dose Methotrexate in the Medical Treatment of Patients Diagnosed With Ectopic Pregnancy

Completed·YYuzuncu Yil University·N/A·NCT06504082·60 enrolled

Assessment of the Efficacy of Letrozole in the Treatment of Ectopic Pregnancy

Unknown status·TTehran University of Medical Sciences·Phase 1/2·NCT05918718·150 enrolled

Show 2 more trials

The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy

Unknown status·—·N/A·NCT04308343·120 enrolled

Study on Combined Use of Letrozole, Mifepristone and Misoprostol in Termination of Pregnancy

Unknown status·TThe University of Hong Kong·N/A·NCT01475318·50 enrolled

51 more indications

Polycystic Ovarian Syndrome4 trials

Comparison Between Letrozole and Urinary Purified FSH in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome.

Completed·—·Phase 3·NCT02304107·140 enrolled

Letrozole or Combined Clomiphene Citrate Metformin as a First Line Treatment in Women With Polycystic Ovarian Syndrome

Completed·—·N/A·NCT01679574·200 enrolled

Letrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome

Unknown status·—·Phase 3·NCT03135301·80 enrolled

Show 1 more trial

Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome

Not yet recruiting·—·Phase 3·NCT06405178·500 enrolled

Endocrine Therapy4 trials

Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy

Active, not recruiting·BBaylor Breast Care Center·Phase 2·NCT00999804·128 enrolled

Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE)

Active, not recruiting·JJules Bordet Institute·Phase 2·NCT04551495·65 enrolled

Select the Appropriate Population for Adding CDK4/6i to Neoadjuvant Endocrine Therapy

Recruiting·YYongsheng Wang·Phase 4·NCT05809024·100 enrolled

Show 1 more trial

Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With HR+ Intraductal Carcinoma of the Breast

Unknown status·FFirst Hospital of China Medical University··NCT04666805·1,354 enrolled

Postmenopausal Women3 trials

Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women

Unknown status·GGangnam Severance Hospital·Phase 2·NCT02214004·132 enrolled

Bevacizumab + Endocrine Treatment vs Endocrine Treatment as First Line in Postmenopausal Women

Completed·SSpanish Breast Cancer Research Group·Phase 3·NCT00545077·380 enrolled

Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast Density

Completed·UUniversity of Virginia·N/A·NCT00114270

Treatment3 trials

Letrozole Treatment in Normal and GnRH Deficient Women

Unknown status·MMassachusetts General Hospital·Phase 1/2·NCT00351416·15 enrolled

Comparison of Treatment Modalities in Poor Responders Undergoing IVF

Completed·EErcan Bastu·N/A·NCT02158689·80 enrolled

Dosage Optimization for Letrozole Treatment

Completed·—·Phase 4·NCT01315912·44 enrolled

Endometriosis3 trials

Letrozole in the Treatment of Severe and Recurrent Endometriosis

Completed· Novartis logo

Novartis·Phase 2·NCT00240942·40 enrolled

Assessment and Prevention of Pain During Ovarian Stimulation in Patients With Endometriosis

Completed·UUniversity of California, San Francisco·Phase 2·NCT04002141·60 enrolled

Letrozole vs Danazol for Endometriosis-Related Pain: Randomized Trial

Completed·SSidra Salman·Phase 2·NCT07183787·60 enrolled

Uterine Leiomyosarcoma2 trials

Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma

Completed·—·Phase 2·NCT00856050·27 enrolled

Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00414076·9 enrolled

Abortion2 trials

Randomized Study of Letrozole and Trilostane for Medical Abortion

Terminated·KKristina Gemzell Danielsson·Phase 2·NCT01615211·36 enrolled

Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion

Completed·—·Phase 2/3·NCT02401425·423 enrolled

Miscarriage2 trials

Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages

Unknown status·—·Phase 3·NCT05304273·120 enrolled

Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage

Not yet recruiting·TThe University of Hong Kong·N/A·NCT06733727·884 enrolled

Growth2 trials

Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole

Completed·SStanford University·Phase 4·NCT02137538·79 enrolled

Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment

Completed·HHelsinki University Central Hospital·Phase 2/3·NCT01797718·35 enrolled

Infertility2 trials

Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility

Completed·—·Phase 3·NCT02739516·108 enrolled

Graceful Lifestyle Changes Study for PCOS and Infertility

Unknown status·UUniversity of British Columbia·N/A·NCT02630485·240 enrolled

Ductal Carcinoma in Situ2 trials

Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT01439711·108 enrolled

Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ

Completed·UUniversity of California, San Francisco·Phase 1/2·NCT00290745·79 enrolled

Obese1 trial

Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT02538484·24 enrolled

Prevention1 trial

Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients

Completed·MMedSIR·Phase 2·NCT04300790·69 enrolled

CLE1 trial

IUI With Letrozole Versus in Natural Cycle

Recruiting·PPeking University Third Hospital·N/A·NCT04169451·982 enrolled

Progesterone1 trial

Letrozole, Herceptin in Her2neu +, Estrogen Receptor [ER] and/or Progesterone Receptor [PR] Positive, MBC

Completed·—·Phase 2·NCT00134680·33 enrolled

Randomized1 trial

IMPACT: A Randomized WOO Study of Novel Therapeutic Agents in Women Triaged to Primary Surgery for EOC

Completed·HHaukeland University Hospital·Phase 1·NCT03378297·26 enrolled

Serous Carcinoma1 trial

Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation

Completed·—·Phase 2/3·NCT03285802·1 enrolled

Fed1 trial

Bioavailability Study of Letrozole Tablets 2.5 mg of Dr.Reddy's Under Fed Conditions

Completed·—·Phase 1·NCT01372982·36 enrolled

Ovarian Cancer1 trial

Ribociclib and Letrozole Treatment in Ovarian Cancer

Active, not recruiting·GGynecologic Oncology Group·Phase 2·NCT03673124·51 enrolled

Breast Neoplasm1 trial

Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms

Completed· Pfizer logo

Pfizer·Phase 2·NCT00062751·108 enrolled

Fasting Conditions1 trial

Bioavailability Study of Letrozole Tablets 2.5 mg of Dr.Reddy's Under Fasting Conditions

Completed·—·Phase 1·NCT01375452·36 enrolled

Observational Study1 trial

Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.

Unknown status·—··NCT04852081·1,000 enrolled

Advanced Solid Cancer1 trial

To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02093351·79 enrolled

TED1 trial

Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fasted Conditions

Completed·RRoxane Laboratories·Phase 1·NCT01367652·28 enrolled

Misoprostol1 trial

The Effect of 7 Days of Letrozole Pretreatment Combined With Misoprostol on the Placental and Decidual Tissues

Completed·TThe University of Hong Kong·Phase 2·NCT02457312·20 enrolled

Overweight1 trial

GCC 1366: Anti-Proliferative Response to NeoAdjuvant AIs in Overweight and Obese Patients

Completed·UUniversity of Maryland, Baltimore·N/A·NCT02095184·42 enrolled

Azoospermia1 trial

Effect of Letrozole on Seminal Parameters in Men With Non Obstructive Azoospermia and Severe Oligozoospermia.

Completed·KKK Women's and Children's Hospital·Phase 3·NCT02900105·28 enrolled

Trial1 trial

CARE Initiative: Real-world Emulation of the PALOMA-2 Trial

Completed·AAetion, Inc.··NCT06607601·724 enrolled

Resistance1 trial

FRAGRANCE Part A Safety: Study to Find a Genetic Signature of de Novo Resistance to Letrozole

Completed·JJules Bordet Institute·Phase 2·NCT00199134·49 enrolled

Intrauterine Insemination1 trial

Study Evaluating the Timing of Intrauterine Insemination in Relation to Positive Home Ovulation Prediction Kit

Completed·MMidwest Fertility Specialists·N/A·NCT02294773·13 enrolled

Cancer Metastatic1 trial

Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls

Unknown status·SSinai Hospital of Baltimore·N/A·NCT02450175·50 enrolled

Ovulation1 trial

The Role of Estrogen in Luteinizing Hormone Surge and Ovulation

Completed·WWake Forest University Health Sciences·Phase 4·NCT01999569·10 enrolled

IVF Outcome1 trial

Vitamin D Supplementation and Improvement of PCOS Therapy and IVF Outcomes in Infertile Saudi Women

Unknown status·UUmm Al-Qura University·N/A·NCT05106712·700 enrolled

Testosterone1 trial

T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin

Completed·UUniversity of Washington·Phase 1/2·NCT01686828·53 enrolled

Abemaciclib1 trial

RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

Recruiting·MMridula George, MD·Phase 1·NCT06139107·15 enrolled

Clinical Trial1 trial

The Clinical Trial of Acupuncture Pre-treatment on PCOS

Completed·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 3·NCT02491320·384 enrolled

PCOS1 trial

Letrozole Dose Increments in PCOS Patients Resistant to Letrozole

Completed·—·Phase 3·NCT06403488·102 enrolled

Osteoporosis1 trial

Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy

Completed·SShanghai Jiao Tong University School of Medicine·Phase 2·NCT02455154·278 enrolled

Ovarian Stimulation1 trial

Effect of Addition of Aromatase Inhibitor to Ovarian Stimulation Therapy in IVF Treatment

Completed·—·Phase 2/3·NCT02946684·129 enrolled

Ovarian cyst1 trial

Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy

Recruiting·TThe University of Hong Kong·N/A·NCT05487092·194 enrolled

Congenital Adrenal Hyperplasia1 trial

Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00001521·66 enrolled

In Vitro Fertilization1 trial

Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization

Completed·NNew Hope Fertility Center·N/A·NCT02865681·4 enrolled

Hyperplasia1 trial

GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia Patients

Active, not recruiting·XXiaojun Chen·Phase 2/3·NCT06390904·29 enrolled

PET1 trial

Palbociclib and FES PET

Completed·UUniversity Medical Center Groningen·Phase 2·NCT02806050·30 enrolled

Endometrial Carcinoma1 trial

A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03008408·90 enrolled

OSA1 trial

Effect of Increased Circulating Androgens on Granulosa Cell Responses to FSH.

Completed·UUniversity of California, San Diego·N/A·NCT02389088·9 enrolled

Acupuncture1 trial

A Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth in Women With PCOS

Unknown status·HHongxia Ma·Phase 3·NCT03625531·1,100 enrolled

MPA1 trial

A Comparison of Letrozole and Clomifene Citrate

Unknown status·TThe University of Hong Kong·N/A·NCT02647424·40 enrolled

Polycystic Ovarian Syndrome (PCOS)1 trial

Comparison Between Letrozole and Laparoscopic Ovarian Drilling in Women With Clomiphene Resistant Polycystic Ovarian Syndrome (PCOS)

Unknown status·—·Phase 3·NCT02305693·140 enrolled

Squamous Cell Carcinoma1 trial

A Trial of Tamoxifen and Letrozole in Recurrent and Persistent Squamous Cell Carcinoma of the Cervix

Unknown status·—·Phase 2·NCT02482740·44 enrolled

Unspecified3 trials

Aromatase Inhibitor Host Factors Study

Completed·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·N/A·NCT01669343·121 enrolled

The Letrozole Administration During Luteal Phase

Unknown status·TThe Affiliated Hospital of Inner Mongolia Medical University·Phase 3·NCT02686151·50 enrolled

Antagonist/Letrozole in Poor Responders

Completed·YYazd Research & Clinical Center for Infertility·Phase 1/2·NCT00823004·120 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 25, 1997

FEMARA

NDA NDA020726

Mar 17, 1999

FEMARA

NDA NDA020726

Apr 22, 1999

FEMARA

NDA NDA020726

May 23, 2000

FEMARA

NDA NDA020726

Jan 10, 2001

FEMARA

NDA NDA020726

Feb 5, 2001

FEMARA

NDA NDA020726

Jan 10, 2002

FEMARA

NDA NDA020726

Jan 17, 2003

FEMARA

NDA NDA020726

Feb 26, 2003

FEMARA

NDA NDA020726

Oct 29, 2004

FEMARA

NDA NDA020726

Dec 28, 2005

FEMARA

NDA NDA020726

Jun 26, 2006

FEMARA

NDA NDA020726

Apr 11, 2007

FEMARA

NDA NDA020726

Aug 7, 2008

FEMARA

NDA NDA020726

Jul 7, 2009

FEMARA

NDA NDA020726

Mar 2, 2010

FEMARA

NDA NDA020726

Mar 2, 2010

FEMARA

NDA NDA020726

Apr 30, 2010

FEMARA

NDA NDA020726

Jun 25, 2010

FEMARA

NDA NDA020726

Dec 23, 2011

FEMARA

NDA NDA020726

Jul 11, 2013

FEMARA

NDA NDA020726

Jan 15, 2014

FEMARA

NDA NDA020726

Dec 23, 2015

FEMARA

NDA NDA020726

Oct 28, 2016

FEMARA

NDA NDA020726

Jul 13, 2017

FEMARA

NDA NDA020726

Apr 5, 2018

FEMARA

NDA NDA020726

Dec 16, 2024

FEMARA

NDA NDA020726

Sources

References

[1]
ClinicalTrials.gov — 529 trial records for Letrozole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Femara drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Letrozole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Letrozole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020726). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cytochrome P450 19a1 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Femara

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Breast Cancer109 trials

Endometrial Cancer5 trials

Ovulation Induction5 trials

Polycystic Ovary Syndrome5 trials

Pregnancy5 trials

Polycystic Ovarian Syndrome4 trials

Endocrine Therapy4 trials

Postmenopausal Women3 trials

Treatment3 trials

Endometriosis3 trials

Uterine Leiomyosarcoma2 trials

Abortion2 trials

Miscarriage2 trials

Growth2 trials

Infertility2 trials

Ductal Carcinoma in Situ2 trials

Obese1 trial

Prevention1 trial

CLE1 trial

Progesterone1 trial

Randomized1 trial

Serous Carcinoma1 trial

Fed1 trial

Ovarian Cancer1 trial

Breast Neoplasm1 trial

Fasting Conditions1 trial

Observational Study1 trial

Advanced Solid Cancer1 trial

TED1 trial

Misoprostol1 trial

Overweight1 trial

Azoospermia1 trial

Trial1 trial

Resistance1 trial

Intrauterine Insemination1 trial

Cancer Metastatic1 trial

Ovulation1 trial

IVF Outcome1 trial

Testosterone1 trial

Abemaciclib1 trial

Clinical Trial1 trial

PCOS1 trial

Osteoporosis1 trial

Ovarian Stimulation1 trial

Ovarian cyst1 trial

Congenital Adrenal Hyperplasia1 trial

In Vitro Fertilization1 trial

Hyperplasia1 trial

PET1 trial

Endometrial Carcinoma1 trial

OSA1 trial

Acupuncture1 trial

MPA1 trial

Polycystic Ovarian Syndrome (PCOS)1 trial

Squamous Cell Carcinoma1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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