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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 18 indications[4].[1]

Trelstar is one of 417 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Approved.

18

Indications

79

Total Trials

14

Active Trials

416

Competitors

4

FDA Applications

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[4][1]

Indication

Prostate AdenocarcinomaApproved

AdenomyosisActive, not recruiting

HypogonadismActive, not recruiting

Prostate CarcinomaApproved

Central Precocious PubertyActive, not recruiting

LymphomaApproved

HIV-1 InfectionApproved

Ovarian ReserveActive, not recruiting

Metastatic Prostate CancerActive, not recruiting

Precocious PubertyApproved

Prostate AdenocarcinomaApproved

Approved

AdenomyosisPreclinical

Active, not recruiting

HypogonadismApproved

Active, not recruiting

Prostate CarcinomaApproved

Approved

Central Precocious PubertyPhase 3

Active, not recruiting

LymphomaApproved

Approved

HIV-1 InfectionApproved

Approved

Ovarian ReservePhase 2

Active, not recruiting

Metastatic Prostate CancerPhase 3

Active, not recruiting

Precocious PubertyApproved

Approved

Showing 10 of 18 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Trelstar

OOncoVerity, Inc.

Halaven

Recentin

NNational Cancer Institute (NCI)

Spravato

Avastin

Nubain

AAultman Health Foundation

Feraheme

AAzurity Pharmaceuticals

Aquasol E

NNational Eye Institute (NEI)

Systemic Therapy

Bristol-Myers Squibb

Beta Blocker

WWeill Medical College of Cornell University

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Prostate Adenocarcinoma

NCT05050084

Q3 2027

ApprovedRecruiting

Deep Infiltrating Endometriosis (DIE)

NCT07696351

Q2 2028

Phase 2Recruiting

Menopause

NCT07254429

Phase 3Active, not recruiting

Prostate Carcinoma

NCT04484818

Phase 2Recruiting

Study completion

NCT05851547

Q4 2028

Metastatic Prostate Cancer

NCT06473259

Clinical

Trials by Indication[1]

Prostate Cancer16 trials

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

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

Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT

Not yet recruiting·BBaptist Health South Florida·Phase 2·NCT07455903·50 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

Show 13 more trials

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

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

Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial

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

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

Completed· Ipsen logo

Ipsen··NCT02238366·368 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

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

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

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

Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

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

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

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

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

Unknown status·—·Phase 3·NCT00003734·276 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

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

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

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

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

Show 7 more trials

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

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

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

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

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

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

Luteal Phase Support4 trials

GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles

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

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

Luteal Phase Support in Insemination Cycles

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

Show 1 more trial

GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles

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

Oocyte Maturation3 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

Intranasal Nafarelin For Triggering Oocyte Maturation

Not yet recruiting·FFundacion Dexeus·Phase 4·NCT06763926·134 enrolled

Metastatic Prostate Cancer3 trials

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

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

Completed· Pfizer logo

Pfizer··NCT05701007·1,083 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

35 more indications

Ovarian Hyperstimulation Syndrome3 trials

Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome

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

Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?

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

Repeated Injection of GnRH Agonist to Reduce Ovarian Hyperstimulation Syndrome

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

Treatment2 trials

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

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

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

Prostate Adenocarcinoma2 trials

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

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

GnRH Antagonist1 trial

Administration of GnRH Antagonist to Oocyte Donation Recipients

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

Ovarian Reserve1 trial

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

Terminated·—·Phase 2·NCT02113553·45 enrolled

Neoadjuvant1 trial

TRial on the Endocrine Activity of Neoadjuvant Degarelix

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

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

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

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

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

Hypogonadism1 trial

MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

Completed·HHerlev Hospital·Phase 4·NCT02102646·31 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

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

Menopause1 trial

COMPASS - COpenhagen MenoPAuSe Study

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

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

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

Endometrial1 trial

Endometrial Receptivity After GnRH Agonist Triggering

Completed·IIVI Madrid·Phase 4·NCT01500863·35 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

Premenopausal1 trial

Premenopausal Endocrine Responsive Chemotherapy Trial

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

Oocyte1 trial

GnRHa Trigger in Asian Oocyte Donors- a Dose Finding Study

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

Women1 trial

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

Completed·—·Phase 4·NCT03169166·277 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

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

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 — 79 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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