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Data updated: Sep 20, 2026

VOBRIG (leuprolide acetate) · Sun Pharma

Approved 2026-08-26

VOBRIG is FDA-approved to treat 3 conditions (same as LUPRON DEPOT).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
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Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2026-08-26
Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

Sun Pharma
Active Ingredient: LEUPROLIDE ACETATE

VOBRIG Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Aug 2026 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What VOBRIG Treats

3 indications

VOBRIG is approved for 3 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Endometriosis
  • Uterine Leiomyomata
  • Anemia

Same approved indications as LUPRON DEPOT (same active ingredient).

Source: FDA Label

Sun Pharma's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

LEQSELVI
2024
DEURUXOLITINIB PHOSPHATE
1 designation
WINLEVI
2020
CLASCOTERONE
1 designation
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Clinical Trial Registry

52 trials
Trial Sponsor ID Phase Status Title
NCT06169124 NCI-2023-06524 NCI-2023-06524, NRG-GY033 Ph 2 active not recruiting Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors
NCT05669664 NCI-2022-10701 NCI-2022-10701, 10553 Ph 2 active not recruiting Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers
NCT03070886 NRG-GU002 NCI-2016-00963, NRG-GU002 Ph 2, Ph 3 active not recruiting Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
NCT04484818 EA8183 NCI-2020-02383, EA8183 Ph 3 active not recruiting Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study
NCT04423211 EA8191 NCI-2020-02686, EA8191 Ph 3 recruiting Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
NCT06305598 I-3298823 NCI-2024-01390, I-3298823 Ph 1 active not recruiting Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer
NCT02960022 9785-CL-0123 2016-001694-32, 2023-510298-33-00 Ph 2 active not recruiting A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
NCT03361735 results posted 17085 NCI-2017-02192 Ph 2 active not recruiting Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
NCT01786265 2012-0993 NCI-2018-01856, 2012-0993 Ph 2 active not recruiting Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer
NCT01674140 e3 results posted S1207 S1207, U10CA032102 Ph 3 active not recruiting S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
NCT04455750 CASPAR A031902 NCI-2020-02360, U10CA180821 Ph 3 active not recruiting A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy
NCT03902951 18-001037 NCI-2019-00337 Ph 2 active not recruiting Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer
NCT04734730 20476 NCI-2020-10199, 20476 Ph 2 recruiting Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
NCT03007732 results posted 16703 NCI-2017-01340 Ph 2 completed Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADT
NCT02023463 13P.461 2013-027, JT 2970 Ph 1 active not recruiting Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer
NCT05896293 FD007843 Ph 2 recruiting Kisspeptin Administration Subcutaneously to Patients With IHH
NCT06348264 SDC-1 Ph 2 recruiting Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma
NCT03678025 S1802 NCI-2018-01738, S1802 Ph 3 recruiting Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
NCT05605964 results posted MVT-601-056 Ph 3 completed Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
NCT02278185 results posted 14-0909.cc NCI-2014-02219 Ph 2 completed Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer
NCT03951831 AAAS1863 Ph 2 active not recruiting REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer
NCT00687739 POWER results posted 06-0512 R01AG018198 Ph 3 completed Prevention of Obesity in Women Via Estradiol Regulation
NCT02685397 PCS IX PCS IX Ph 2, Ph 3 active not recruiting Management of Castration-Resistant Prostate Cancer with Oligometastases
NCT01194271 results posted 2009-0135 NCI-2010-01974 Ph 2 completed Neoadjuvant Ipilimumab in Prostate Cancer
NCT00651326 DART PR12 CAN-NCIC-PR12, CDR0000589247 Ph 3 terminated Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer
NCT00771017 CDR0000616570 ECOG-E3806 Ph 2 withdrawn Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer
NCT02058706 results posted 2013-083 NCI-2014-00212, 2013-083 Ph 2 completed LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Hormone Sensitive Prostate Cancer
NCT03043807 results posted J16151 IRB00120414 Ph 2 completed A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy
NCT02716974 oligo-mets results posted J1618 IRB00070003 Ph 2 completed A Study of Definitive Therapy to Treat Prostate Cancer
NCT04225221 results posted 19-2343 R21MH121726 Ph 2 completed Neurobiology of Bulimia Nervosa
NCT02770391 results posted CASE5815 Ph 2 completed Apalutamide and Leuprolide in Intermediate and High-risk Prostate Cancer
NCT02268175 results posted 14-283 Ph 2 completed Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate
NCT03085095 HERO results posted MVT-601-3201 2017-000160-15 Ph 3 completed A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer
NCT04585932 2019-1093 NCI-2020-02553, 2019-1093 Ph 2 withdrawn Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study
NCT02064582 results posted STU 082013-032 Ph 2 completed Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer
NCT02168062 results posted 135513 NCI-2015-01058 Ph 2 terminated Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer
NCT03093272 results posted 16-485 Ph 2 terminated A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer
NCT00937768 results posted MC0852 NCI-2009-01147, 08-001519 Ph 2 terminated Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
NCT02969590 results posted OHSU IRB 11532 Ph 4 completed Regulation of Cervical Mucus Secretion
NCT03544073 GRAET 2018-03-14 Ph 3 withdrawn GnRH Agonist at Embryo Transfer: IVF Outcomes
NCT01163084 results posted NCI-2010-01737 NCI-2010-01737, CDR0000670590 Ph 1, Ph 2 terminated Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer
NCT01120236 results posted NCI-2011-02003 NCI-2011-02003, SWOG-S0925 Ph 2 completed Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer
NCT01023061 RAD1 results posted 7048 NCI-2009-01346, 7048 - AbiRAD Ph 2 completed Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer
NCT01431391 results posted P10-2 Ph 2 completed Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
NCT02107391 SP002 2011-004986-34 Ph 2 completed Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer
NCT02212197 results posted HS-12-460 Ph 2 completed Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
NCT00943956 CDR0000639358 CLCC-RHOMUS, CRAD001 C2486 Ph 1 completed Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer
NCT00949962 EORTC-22043-30041 EU-20950, 2006-002772-17 Ph 3 terminated Post-operative or Early Salvage XRT and ADT for High Risk PCa
NCT01161563 results posted TRE1001 Ph 4 completed Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration
NCT00805935 results posted 2008-05 Ph 4 completed Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)

Showing 50 of 52 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

VOBRIG FDA Label Details

Indications & Usage

FDA Label (PDF)

VOBRIG is FDA-approved to treat 3 conditions — same approved indications as LUPRON DEPOT.

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Data Sources

FDA Approval: NDA213225 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.