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← All drugs Report issue

relugolix

Trade name: ORGOVYX

Small moleculeapproved

Approved

Dec 18, 2020

Relugolix, sold under the brand names Orgovyx and Relumina among others, is a gonadotropin-releasing hormone antagonist medication which is used in the treatment of prostate cancer, uterine fibroids and endometriosis. It is taken by mouth. — Wikipedia

Clinical trial activity

53 trials · 38 clinical orgs · 3 marketing orgs

Phase 1
13
Phase 2
38
Phase 3
21
Phase 4
2

Earliest trial started Oct 1, 2011 (NCT01452659)

Timeline

2010s

  1. Jan 1, 2011

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2016

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Dec 18, 2020

    Sumitomo Dainippon — Earliest FDA Approval

  2. Dec 18, 2020

    Myovant Sciences GmbH — Marketing Organization

  3. Dec 18, 2020

    Sumitomo Dainippon — NDA Secondary Org

  4. Dec 18, 2020

    Sumitomo Dainippon — NDA Organization

  5. Dec 18, 2020

    Sumitomo — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewDec 18, 2020

Chemistry & pharmacology

Loading structure…

SMILES

CONC(=O)Nc1ccc(-c2sc3c(c2CN(C)C)c(=O)n(-c2ccc(OC)nn2)c(=O)n3Cc2c(F)cccc2F)cc1
Mol. weight
623.64 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 1-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno(2,3-d)pyrimidin-6-yl)phenyl)-3-methoxyurea
  • relugolix
  • relugolix
  • relugolix
  • relugolix
  • tak385
  • tak 385
  • tak-385
  • tak-385
  • tak-385
  • tak-385

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07302451Phase 2Dec 1, 2025Fondazione Giovanni Pascale
NCT07100782Phase 3Nov 30, 2025National Institutes of Health (NIH), University of Michigan
NCT07216248Phase 2Oct 27, 2025University of Utah
NCT07173127N/ASep 30, 2025University of Geneva
NCT07111247Phase 4Aug 31, 2025National Institutes of Health (NIH), Oregon Health and Science University
NCT07025369Phase 2Aug 25, 2025Mayo Clinic
NCT06671548Phase 3Jan 31, 2025Qilu Pharmaceutical Co., Ltd.
NCT06650579Phase 3Dec 16, 2024Emory University, National Cancer Institute (NCI), National Comprehensive Cancer Network, Pfizer, Sumitomo Dainippon
NCT06463457Phase 2Nov 30, 2024Bayer, Harvard University, National Comprehensive Cancer Network, Pfizer, Sumitomo
NCT06631521Phase 1Oct 22, 2024Advent Health, Bayer
NCT06499870Phase 2Sep 6, 2024National Cancer Institute (NCI), Northwestern University
NCT06439524Phase 3Aug 15, 2024Main Line Health, Pfizer
NCT06330805Phase 2Aug 12, 2024Myovant Sciences GmbH, Ohio State University, Pfizer, Sumitomo
NCT07069465Early Phase 1 (Phase 1)Jun 15, 2024Blue Earth Diagnostics, Texas Health Resources, Urology Clinics of North Texas
NCT06378866Phase 2Jun 3, 2024Mayo Clinic
NCT06312761Phase 1/Phase 2 (Phase 2)Jun 1, 2024University of Washington, Washington State University
NCT06397703Phase 3Apr 16, 2024New York University
NCT06111313Phase 2Mar 1, 2024University of Miami, Varian Medical Systems
NCT05765500Phase 2Jan 31, 2024Harvard University, Myovant Sciences GmbH, Pfizer, Prostate Cancer Foundation
NCT06130995Phase 1Jan 31, 2024University of Oklahoma
Showing 20 of 53 trials
Page 1 / 3

Organizations

Research & Development (38)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Myovant Sciences GmbHFor profit161432016
TakedaFor profit9932011
National Cancer Institute (NCI)Government6032021
PfizerFor profit6022024
Millennium PharmaceuticalsFor profit3322014
BayerFor profit2022024
Emory UniversityAcademic/Hospital2222022
Harvard UniversityAcademic/Hospital2212024
Mayo ClinicAcademic/Hospital2212024
National Comprehensive Cancer NetworkAcademic/Hospital2022024
National Institutes of Health (NIH)Government2022025
NRG OncologyAcademic/Hospital2222021
SumitomoFor profit2012024
Advent HealthAcademic/Hospital1112024
ASKA Pharmaceutical Co., Ltd.For profit1112019
Blue Earth DiagnosticsFor profit1012024
Fondazione Giovanni PascaleAcademic/Hospital1112025
Main Line HealthAcademic/Hospital1112024
New York UniversityAcademic/Hospital1112024
Northwestern UniversityAcademic/Hospital1112024
38 organizations
Page 1 / 2

Marketing (4)

OrganizationOrg typeRelationshipDate
Myovant Sciences GmbHFor profitMKTGDec 18, 2020
SumitomoFor profitNDA2Dec 18, 2020
Sumitomo DainipponFor profitNDA2Dec 18, 2020
Sumitomo DainipponFor profitNDADec 18, 2020