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Trelstar

(Triptorelin)

ApprovedSmall molecule

OOncoVerity, Inc.

Triptorelin is used to treat advanced prostate cancer by lowering testosterone levels, and it's also used to treat endometriosis and uterine fibroids in women by reducing estrogen production.[2] Trelstar is currently approved and in use across 19 indications[4].[1]

Trelstar is one of 390 small molecule programs targeting Prostatic Neoplasms. It is currently in Approved.

19

Indications

80

Total Trials

15

Active Trials

389

Competitors

4

FDA Applications

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[4][1]

Indication

Prostatic NeoplasmsRecruiting

AdenomyosisActive, not recruiting

InfertilityApproved

EndometriosisApproved

LymphomaApproved

HIV-1 InfectionApproved

Polycystic Ovary SyndromeActive, not recruiting

Deep Infiltrating Endometriosis (DIE)Recruiting

HypogonadismActive, not recruiting

Biochemically Recurrent Prostate CarcinomaRecruiting

Prostatic NeoplasmsPhase 2

Recruiting

AdenomyosisPreclinical

Active, not recruiting

InfertilityApproved

Approved

EndometriosisApproved

Approved

LymphomaApproved

Approved

HIV-1 InfectionApproved

Approved

Polycystic Ovary SyndromePreclinical

Active, not recruiting

Deep Infiltrating Endometriosis (DIE)Approved

Recruiting

HypogonadismApproved

Active, not recruiting

Biochemically Recurrent Prostate CarcinomaPhase 3

Recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Trelstar

OOncoVerity, Inc.

Zofran

Norvir

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Kenalog

BBausch Health Americas, Inc.

Nuvigil

NNuvo Research GmbH

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Decadron

QQuince Therapeutics S.p.A.

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

Bristol-Myers Squibb

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

Timeline

Expected Milestones

Q3 2027

ApprovedRecruiting

Deep Infiltrating Endometriosis (DIE)

NCT07696351

Q1 2028

Phase 3Recruiting

Ovarian Reserve

NCT07816562

ApprovedNot yet recruiting

Fertility Preservation

NCT06763926

Q2 2028

Phase 2Recruiting

Menopause

NCT07254429

Phase 3Active, not recruiting

Prostate Carcinoma

NCT04484818

Phase 2Recruiting

Study completion

NCT05851547

Clinical

Trials by Indication[1]

Prostate Cancer14 trials

Hormone Therapy in Treating Patients With Advanced Prostate Cancer

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00003026·966 enrolled

Investigation of Early Hormonotherapy Efficacy of Prostate Cancer

Unknown status·UUnknown Sponsor·N/A·NCT00375687·61 enrolled

Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer

Completed· Ipsen logo

Ipsen··NCT02238366·368 enrolled

Show 11 more trials

Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients

Unknown status·WWonju Severance Christian Hospital·Phase 4·NCT04248621·164 enrolled

Management of Castration-Resistant Prostate Cancer with Oligometastases

Active, not recruiting·SSir Mortimer B. Davis - Jewish General Hospital·Phase 2/3·NCT02685397·102 enrolled

Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer

Completed·UUNICANCER·Phase 3·NCT00667069·424 enrolled

Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer

Completed· Ipsen logo

Ipsen·Phase 3·NCT01020448·339 enrolled

Study to Assess the Non-inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer (PAMOJECT)

Terminated· Ipsen logo

Ipsen·Phase 2·NCT00444639·25 enrolled

Study to Assess the Efficacy of Brachytherapy With or Without Hormone Therapy, Using Triptorelin 22.5mg in Patients With Recurrence of Prostate Cancer

Terminated· Ipsen logo

Ipsen·Phase 2·NCT01374087·32 enrolled

Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer

Unknown status·—·Phase 3·NCT00003734·276 enrolled

A Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients.

Completed· Ipsen logo

Ipsen·Phase 4·NCT01753297·226 enrolled

Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer

Completed·UUNICANCER·Phase 3·NCT00104741·378 enrolled

Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer

Completed·UUniversity of Colorado, Denver·Phase 2·NCT02278185·19 enrolled

Assessing the Efficacy of Neoadjuvant Androgen Deprivation Therapy (ADT) Utilizing 18F-Flotufolastat PSMA PET/CT in Patients With High-Risk Localized Prostate Cancer (LHRPC)

Recruiting·BBaptist Health South Florida·Phase 2·NCT07455903·50 enrolled

Breast Cancer10 trials

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

Completed·EETOP IBCSG Partners Foundation·Phase 3·NCT00066690·3,066 enrolled

Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer

Active, not recruiting·SSOLTI Breast Cancer Research Group·Phase 2·NCT05982093·48 enrolled

A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer

Completed·EETOP IBCSG Partners Foundation·Phase 2·NCT05896566·231 enrolled

Show 7 more trials

Triptorelin in Preventing Early Menopause in Premenopausal Women Who Are Receiving Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery

Completed·GGruppo Italiano Mammella (GIM)·Phase 3·NCT00311636·280 enrolled

Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02

Completed·EETOP IBCSG Partners Foundation·Phase 3·NCT00659373·86 enrolled

Neoadjuvant Chemo-endocrine Therapy and Immunotherapy for Pre-menopausal Luminal B Breast Cancer Patients

Completed·IIstituto Oncologico Veneto IRCCS·Phase 2·NCT04659551·43 enrolled

Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer

Terminated·UUniversity of South Florida·Phase 2·NCT00090844·49 enrolled

Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

Completed·EETOP IBCSG Partners Foundation·Phase 3·NCT00066703·2,672 enrolled

Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia

Unknown status·—··NCT05800197·300 enrolled

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

Luteal Phase Support4 trials

GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles

Unknown status·MMansoura University·Phase 4·NCT02312076·200 enrolled

Luteal Phase Support in Insemination Cycles

Completed·TTampere University Hospital·Phase 4·NCT03115307·167 enrolled

GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles

Unknown status·MMansoura University·Phase 4·NCT02312089·200 enrolled

Show 1 more trial

GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Bolus of GnRHa at the Time of Implantation - a RCT

Completed·—·Phase 3·NCT02053779·328 enrolled

Ovarian Hyperstimulation Syndrome3 trials

Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome

Unknown status·CChenshiling·N/A·NCT02022228·200 enrolled

Repeated Injection of GnRH Agonist to Reduce Ovarian Hyperstimulation Syndrome

Unknown status·CChenshiling·N/A·NCT02022241·80 enrolled

Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?

Terminated·EElisha Hospital·Phase 4·NCT01714648·6 enrolled

Metastatic Prostate Cancer3 trials

Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland

Completed· Pfizer logo

Pfizer··NCT05701007·1,083 enrolled

Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

Recruiting·SSWOG Cancer Research Network·Phase 3·NCT03678025·1,273 enrolled

Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients

Recruiting·SSanta Chiara Hospital··NCT06473259·3,000 enrolled

38 more indications

Androgen Deprivation Therapy2 trials

Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)

Unknown status·FFudan University·Phase 2·NCT02742675·200 enrolled

Micro RNAs to Predict Response to Androgen Deprivation Therapy

Completed·MMedical College of Wisconsin··NCT02366494·42 enrolled

Treatment2 trials

Corifollitropin Alfa Followed by hpHMG in a Long GnRH Agonist Protocol for the Treatment of Poor Ovarian Responders

Completed·UUniversitair Ziekenhuis Brussel·Phase 2·NCT01732094·57 enrolled

Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol

Completed·UUniversitair Ziekenhuis Brussel·Phase 2·NCT01732068·51 enrolled

Precocious Puberty2 trials

Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children

Unknown status·UUniversity of Pisa·Phase 4·NCT00438217·100 enrolled

Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study

Completed· Ipsen logo

Ipsen·Phase 3·NCT00909844·35 enrolled

Oocyte Maturation2 trials

DEPO-Trigger Trial: GnRH Agonist DEPOt TRIGGER for Final Oocyte Maturation

Unknown status·UUniversitair Ziekenhuis Brussel·Phase 1/2·NCT04616729·30 enrolled

COMPARING TWO PROTOCOLS FOR FINAL OOCYTE MATURATION IN POOR RESPONDERS UNDERGOING GnRH-ANTAGONIST ICSI CYCLES

Unknown status·—·Phase 3·NCT05397795·160 enrolled

Ovarian Reserve2 trials

Anti-Mullerian Hormone (AMH) as Marker of Ovarian Reserve

Terminated·—·Phase 2·NCT02113553·45 enrolled

Ovulation Trigger Strategies in Women With Low Ovarian Reserve Undergoing Fresh In Vitro Fertilization Cycles: A Prospective Randomized Controlled Trial (TRIGGERBEST)

Recruiting·FFundación para la Investigación del Hospital Clínico de Valencia·Phase 3·NCT07816562·126 enrolled

Prostate Adenocarcinoma2 trials

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)

Active, not recruiting·NNRG Oncology·Phase 3·NCT04513717·2,753 enrolled

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

Active, not recruiting·NNRG Oncology·Phase 3·NCT05050084·2,050 enrolled

Single Dose1 trial

Single Dose Recombinant Human Follicle Stimulating Hormone Fc Husion Protein (KN015) in Healthy Volunteers

Unknown status·AAlphamab Jilin Co., Ltd.·Phase 1·NCT03192527·50 enrolled

Outcome1 trial

Dydrogesterone, Cetrorelix Acetate and Triptorelin in Intra Cytoplasmic Sperm Injection Outcomes

Unknown status·—·Phase 3·NCT05972902·387 enrolled

Pregnancy1 trial

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783)

Completed·OOrganon and Co··NCT00702520·15 enrolled

Central precocious puberty1 trial

Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty

Completed·DDebiopharm International SA·Phase 3·NCT01467882·44 enrolled

Adenomyosis1 trial

Adenomyosis and Pregnancy: Levonorgestrel vs. GnRH for Blastocyst Transfer

Completed·ZZagazig University·N/A·NCT06581679·184 enrolled

Chemotherapy1 trial

Efficiency of Gonadotropin-releasing Hormone (GnRH) Agonist in Preventing Chemotherapy Induced Ovarian Failure

Completed·EErasme University Hospital·Phase 2/3·NCT01160315·118 enrolled

Progesterone1 trial

Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle

Completed·—·N/A·NCT04846218·100 enrolled

Oocyte1 trial

GnRHa Trigger in Asian Oocyte Donors- a Dose Finding Study

Completed·VVietnam National University·N/A·NCT02208986·165 enrolled

Hypogonadism1 trial

MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

Completed·HHerlev Hospital·Phase 4·NCT02102646·31 enrolled

Endometriosis1 trial

Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients

Completed·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT02400801·166 enrolled

Ovarian Stimulation1 trial

Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days

Completed·FFertility - Assisted Fertilization Center·N/A·NCT01468441·96 enrolled

Effectiveness1 trial

Effectiveness and Safety Study of Fixed Versus Flexible of Gonadotropin-releasing Hormone Antagonist Protocol

Unknown status·CChong Qing Reproducive and Genetic Institute·N/A·NCT02635607·200 enrolled

Growth1 trial

A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height

Unknown status·BBelgian Study Group for Pediatric Endocrinology·Phase 4·NCT00840944·44 enrolled

Controlled Ovarian Stimulation1 trial

A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703)

Completed·OOrganon and Co·Phase 3·NCT00725491·259 enrolled

Lymphoma1 trial

Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients

Completed·MMasaryk University·N/A·NCT01764230·72 enrolled

Menopause1 trial

COMPASS - COpenhagen MenoPAuSe Study

Recruiting·MMartin Blomberg Jensen·Phase 2·NCT07254429·192 enrolled

GnRH Antagonist1 trial

Administration of GnRH Antagonist to Oocyte Donation Recipients

Completed·CCentro Ginecologia y Obstetricia.··NCT00635258·100 enrolled

Frozen Embryo Transfer1 trial

the Effects of GnRHa Add up to Routine Luteal Phase Support on Frozen Embryo Implantation in Frozen Embryo Transfer .

Unknown status·CChong Qing Reproducive and Genetic Institute·Phase 4·NCT02655146·700 enrolled

Hysteroscopic Myomectomy1 trial

GnRH Agonist Pretreatment in Hysteroscopic Myomectomy

Completed·AAzienda Ospedaliera S. Maria della Misericordia·N/A·NCT01873378·84 enrolled

RCT1 trial

GNRH Agonist Trigger and Modified Luteal Phase Adding a Bolus of GnRHa at the Time of Implantation: a RCT

Completed·—·Phase 3·NCT03039049·328 enrolled

Embryo Transfer1 trial

Long Protocol and Freeze All Embryos vs Antagonist Protocol With Fresh Embryo Transfer in PCOS Patients Undergoing ICSI

Completed·—·Phase 4·NCT03118830·204 enrolled

Polycystic Ovary Syndrome1 trial

Progestin-primed Ovarian Stimulation Protocol Versus GnRH Antagonist Protocol in Polycystic Ovary Syndrome Patients Undergoing IVF/ICSI Cycles

Unknown status·MMansoura University·N/A·NCT05112692·200 enrolled

Endometrial1 trial

Endometrial Receptivity After GnRH Agonist Triggering

Completed·IIVI Madrid·Phase 4·NCT01500863·35 enrolled

Women1 trial

The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies

Completed·—·Phase 4·NCT03169166·277 enrolled

Premenopausal1 trial

Premenopausal Endocrine Responsive Chemotherapy Trial

Terminated·EETOP IBCSG Partners Foundation·Phase 3·NCT00066807·29 enrolled

Fertility Preservation1 trial

Intranasal Nafarelin Compared to Subcutaneous Triptorelin for Triggering Final Oocyte Maturation in Ovarian Stimulation: a Non-inferiority Randomised Controlled Clinical Trial

Not yet recruiting·FFundacion Dexeus·Approved·NCT06763926·154 enrolled

Breast Cancer Invasive1 trial

A Randomized Phase II Trial Evaluating the Endocrine Activity and Efficacy of Neoadjuvant Degarelix Versus Triptorelin in Premenopausal Patients Receiving Letrozole for Primary Endocrine Responsive Breast Cancer

Completed·EETOP IBCSG Partners Foundation·Phase 2·NCT02005887·51 enrolled

Biochemically Recurrent Prostate Carcinoma1 trial

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Recruiting·EECOG-ACRIN Cancer Research Group·Phase 3·NCT04423211·804 enrolled

Prostate Carcinoma1 trial

A Phase III Double Blinded Study of Early Intervention After RADICAl ProstaTEctomy With Androgen Deprivation Therapy With or Without Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE)

Active, not recruiting·EECOG-ACRIN Cancer Research Group·Phase 3·NCT04484818·27 enrolled

Recurrent Castration-Sensitive Prostate Carcinoma1 trial

MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer

Recruiting·MMayo Clinic·Phase 2·NCT06378866·532 enrolled

Deep Infiltrating Endometriosis (DIE)1 trial

A Randomized Controlled Study of Ultra-Long GnRH-a Pretreatment to Improve Frozen-Thawed Embryo Transfer Outcomes in Patients With Deep Infiltrating Endometriosis

Recruiting·LLi-jun Ding·Approved·NCT07696351·120 enrolled

Unspecified3 trials

Miniflare Versus Long Protocol in Poor Responders

Unknown status·WWoman's Health University Hospital, Egypt·N/A·NCT02681536·200 enrolled

Generation of Biological Samples Positive to Triptorelin for Anti-doping Control

Completed·PParc de Salut Mar·Phase 1·NCT04189900·2 enrolled

Dose Escalation For INtraprostatic LEsions

Recruiting·OOttawa Hospital Research Institute·Phase 2·NCT05851547·54 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 15, 2000

TRELSTAR

NDA NDA020715

Jun 29, 2001

TRELSTAR

NDA NDA021288

Mar 10, 2010

TRELSTAR

NDA NDA022437

Jun 29, 2017

TRIPTODUR KIT

NDA NDA208956

Sources

References

[1]
ClinicalTrials.gov — 80 trial records for Triptorelin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Trelstar drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Triptorelin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Triptorelin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208956). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Trelstar. U.S. Food & Drug Administration.
[7]
SEC EDGAR — OncoVerity, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Gonadotropin-Releasing Hormone Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: OOncoVerity, Inc.

Patent Landscape[6]

Patent Cliff

Jun 30, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10166181Jun 30, 2029

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