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leuprolide

Trade name: lupron

Small moleculeapproved

Approved

Apr 9, 1985

Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. It acts primarily on the anterior pituitary, inducing a transient early rise in gonadotrophin release. With continued use, leuprorelin causes pituitary desensitisation and/or down-regulation, leading to suppressed circulating levels of gonadotrophins and sex hormones. Leuprolide acetate used to treat a wide range of sex hormone-related disorders including advanced prostatic cancer, uterine leiomyomata (fibroids), endometriosis and precocious puberty. — NCATS

Clinical trial activity

370 trials · 304 clinical orgs · 25 marketing orgs

Phase 1
36
Phase 2
259
Phase 3
109
Phase 4
45

Earliest trial started Jul 1, 1989 (NCT00004311)

Timeline

1980s

  1. Apr 9, 1985

    Earliest FDA Approval

  2. Apr 9, 1985

    AbbVie — NDA Secondary Org

  3. Jan 1, 1989

    Earliest Phase 2 Sponsor(trial)

1990s

  1. Jan 1, 1991

    Abbott — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 1992

    Earliest Phase 1 Sponsor(trial)

  3. Mar 30, 1995

    Abbott — NDA Secondary Org

  4. Aug 4, 1998

    Sandoz — Marketing Organization

  5. Aug 4, 1998

    Novartis — Marketing Organization

2000s

  1. Mar 3, 2000

    Johnson and Johnson — NDA Secondary Org

  2. Oct 25, 2000

    Teva — Marketing Organization

  3. Oct 25, 2000

    Eu Yan Sang — Marketing Organization

  4. Oct 25, 2000

    Meitheal — Marketing Organization

  5. Nov 29, 2001

    Genzyme — Marketing Organization

  6. Jan 23, 2002

    Tolmar Inc. — NDA Secondary Org

  7. Mar 9, 2009

    Sun Pharmaceuticals — Marketing Organization

2010s

  1. Dec 14, 2012

    AbbVie — Marketing Organization

  2. Aug 28, 2018

    GP-Pharm — NDA Secondary Org

  3. Aug 28, 2018

    Invagen Pharms — Marketing Organization

  4. Aug 28, 2018

    Cipla — NDA Secondary Org

2020s

  1. May 1, 2020

    Tolmar Inc. — Marketing Organization

  2. May 25, 2021

    Foresee Pharmaceuticals Co., Ltd. — Marketing Organization

  3. May 25, 2021

    Accord Research — Marketing Organization

  4. May 25, 2021

    Accord Research — NDA Secondary Org

  5. Aug 13, 2021

    Vgyaan — Marketing Organization

  6. Aug 13, 2021

    Apicore — Marketing Organization

  7. Aug 13, 2021

    Somerset Pharmaceuticals — Marketing Organization

  8. Jun 6, 2022

    Eugia Pharma — Marketing Organization

  9. Oct 28, 2022

    Amneal Pharmaceuticals — Marketing Organization

  10. Oct 17, 2024

    UBI Pharma Inc. — Marketing Organization

  11. Jun 9, 2025

    PH HEALTH — Marketing Organization

  12. Nov 13, 2025

    Zydus Discovery DMCC — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewApr 9, 1985

Chemistry & pharmacology

Loading structure…

SMILES

CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1c[nH]cn1)NC(=O)[C@@H]1CCC(=O)N1
Mol. weight
1209.42 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • abbott-43818
  • abbott-43818
  • carcinil
  • carcinil
  • (d-leu(6),des-gly-nh2(10),pro-ethylamide(9))-gonadotropin-releasing hormone
  • (d-leu(6),des-gly-nh2(10),pro-ethylamide(9))-gonadotropin-releasing hormone
  • eligard
  • eligard
  • eligard
  • eligard
  • eligard
  • leupline
  • leuporelin
  • leuprolide
  • leuprolide
  • leuprolide
  • leuprolide
  • leuprolide
  • leuprolide
  • leuprolide
  • leuprolide acetate
  • leuprolide acetate
  • leuprolide acetate
  • leuprolide acetate
  • leuprolide acetate
  • leuprolide mesylate
  • leuprorelin
  • leuprorelin
  • leuprorelin
  • leuprorelin
  • leuprorelin
  • leuprorelin
  • leuprorelin
  • leuprorelin
  • leuprorelina
  • leuprorelina
  • leuprorelin acetate
  • leuproreline
  • leuproreline
  • leuprorelinum
  • leuprorelinum
  • lo2a
  • l-pyroglutamyl-l-histidyl-l-tryptophyl-l-seryl-l-tyrosyl-d-leucyl-l-leucyl-l-arginyl-l-proline ethylamide
  • l-pyroglutamyl-l-histidyl-l-tryptophyl-l-seryl-l-tyrosyl-d-leucyl-l-leucyl-l-arginyl-l-proline ethylamide
  • lucrine
  • luprolide acetate gel depot
  • lupron
  • lupron
  • lupron
  • lupron
  • lupron depot
  • lupron depot ped
  • lupron depot-ped
  • pglu-his-trp-ser-tyr-d-leu-leu-arg-pro-nhc2h5
  • pglu-his-trp-ser-tyr-d-leu-leu-arg-pro-nhc2h5
  • pglu-his-trp-ser-tyr-d-leu-leu-arg-pro-nhet
  • pglu-his-trp-ser-tyr-d-leu-leu-arg-pro-nhet
  • tap-144
  • tap-144
  • tap-144
  • viadur
  • viadur

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07158021Phase 2Dec 1, 2025University of Michigan
NCT07159451Phase 2Sep 23, 2025Institut Gustave Roussy, Menarini Group
NCT07179939Phase 2Sep 10, 2025Fudan University, Hengrui Therapeutics, Inc., People's Liberation Army of China
NCT07158346Phase 1Aug 18, 2025Celltrion
NCT07027124Phase 2Jun 30, 2025Bayer, Icahn School of Medicine at Mount Sinai, Merck
NCT07015268Phase 3Jun 30, 2025Kissei Pharmaceuticals
NCT06654336Phase 2Apr 15, 2025McMaster University
NCT06855589Phase 3Mar 31, 2025CSSS Champlain - Charles-Lemoyne Hospital, McGill University
NCT06650579Phase 3Dec 16, 2024Emory University, National Cancer Institute (NCI), National Comprehensive Cancer Network, Pfizer, Sumitomo Dainippon
NCT06305598Phase 1Dec 15, 2024State University of New York, Buffalo
NCT06926933Phase 4Dec 12, 2024HanAll BioPharma Co., Ltd.
NCT06627530Phase 4Oct 31, 2024Bayer, Brazilian Clinical Research Institute
NCT06330805Phase 2Aug 12, 2024Myovant Sciences GmbH, Ohio State University, Pfizer, Sumitomo
NCT06449027Phase 3Jun 30, 2024Fudan University, GeneScience Pharmaceuticals Co., Ltd.
NCT06378866Phase 2Jun 3, 2024Mayo Clinic
NCT06490328Phase 3May 30, 2024Dongkook Pharmaceutical Co., Ltd., Ewha Womans University
NCT06397703Phase 3Apr 16, 2024New York University
NCT06348264Phase 2Mar 30, 2024Hengrui Therapeutics, Inc., Peking University
NCT06225284Phase 2Feb 15, 2024Debiopharm, National Taiwan University
NCT05765500Phase 2Jan 31, 2024Harvard University, Myovant Sciences GmbH, Pfizer, Prostate Cancer Foundation
Showing 20 of 370 trials
Page 1 / 19

Organizations

Research & Development (304)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government541641994
Harvard UniversityAcademic/Hospital241551993
University of Texas at HoustonAcademic/Hospital191431999
TakedaFor profit121231996
AstellasFor profit11542006
Johns Hopkins UniversityAcademic/Hospital11632008
Cornell UniversityAcademic/Hospital10741998
Janssen Pharmaceutica NVFor profit10022013
National Institutes of Health (NIH)Government10242000
FerringFor profit9532006
Southwest Oncology GroupAcademic/Hospital9321995
University of WashingtonAcademic/Hospital9621997
AbbottFor profit8541991
NRG OncologyAcademic/Hospital8322005
University of MichiganAcademic/Hospital8432001
Fudan UniversityAcademic/Hospital7632013
PfizerFor profit7032006
University of ChicagoAcademic/Hospital7541994
University of Colorado, DenverAcademic/Hospital7732008
BayerFor profit6132008
304 organizations
Page 1 / 16

Marketing (29)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Apr 9, 1985
AbbVieFor profitMKTGDec 14, 2012
AbbottFor profitNDA2Mar 30, 1995
Accord ResearchFor profitMKTGMay 25, 2021
Accord ResearchFor profitNDA2May 25, 2021
Amneal PharmaceuticalsFor profitMKTGOct 28, 2022
ApicoreFor profitMKTGAug 13, 2021
CiplaFor profitNDA2Aug 28, 2018
Eu Yan SangFor profitMKTGOct 25, 2000
Eugia PharmaFor profitMKTGJun 6, 2022
Foresee Pharmaceuticals Co., Ltd.For profitMKTGMay 25, 2021
GP-PharmFor profitNDA2Aug 28, 2018
GenzymeFor profitMKTGNov 29, 2001
Invagen PharmsFor profitMKTGAug 28, 2018
Johnson and JohnsonFor profitNDA2Mar 3, 2000
MeithealFor profitMKTGOct 25, 2000
NovartisFor profitMKTGAug 4, 1998
PH HEALTHFor profitMKTGJun 9, 2025
SandozFor profitMKTGAug 4, 1998
Somerset PharmaceuticalsFor profitMKTGAug 13, 2021
Sun PharmaceuticalsFor profitSYNMar 9, 2009
Sun PharmaceuticalsFor profitMKTGMar 9, 2009
TAP PharmaceuticalsFor profitNDA—
TevaFor profitMKTGOct 25, 2000
Tolmar Inc.For profitNDA2Jan 23, 2002
Tolmar Inc.For profitMKTGMay 1, 2020
UBI Pharma Inc.For profitMKTGOct 17, 2024
VgyaanFor profitMKTGAug 13, 2021
Zydus Discovery DMCCFor profitMKTGNov 13, 2025