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clomifene

Trade name: clomid

Small moleculeapproved

Approved

Feb 1, 1967

Clomiphene (CLOMID®) is a triphenyl ethylene stilbene derivative which is an estrogen agonist or antagonist depending on the target tissue. It is an orally administered, nonsteroidal, ovulatory stimulant. Clomiphene (CLOMID®) is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer. Clomiphene (CLOMID®) initiates a series of endocrine events culminating in a preovulatory gonadotropin surge and subsequent follicular rupture. The first endocrine event in response to a course of clomiphene therapy is an increase in the release of pituitary gonadotropins. This initiates steroidogenesis and folliculogenesis, resulting in growth of the ovarian follicle and an increase in the circulating level of estradiol. Following ovulation, plasma progesterone and estradiol rise and fall as they would in a normal ovulatory cycle. — NCATS

Clinical trial activity

146 trials · 130 clinical orgs · 9 marketing orgs

Phase 1
15
Phase 2
43
Phase 3
24
Phase 4
47

Earliest trial started Mar 1, 1991 (NCT01340521)

Timeline

1960s

  1. Feb 1, 1967

    Sanofi — Earliest FDA Approval

  2. Feb 1, 1967

    Sanofi-Aventis — NDA Secondary Org

  3. Feb 1, 1967

    Sanofi — NDA Organization

1980s

  1. Mar 22, 1982

    Merck Serono — NDA Secondary Org

  2. Dec 20, 1988

    Granata Bio — Marketing Organization

  3. Dec 20, 1988

    Milex Products, Inc — Marketing Organization

1990s

  1. Jan 1, 1991

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1997

    Earliest Phase 3 Sponsor(trial)

  3. Aug 30, 1999

    Cosette — Marketing Organization

  4. Aug 30, 1999

    Par Pharmaceuticals — Marketing Organization

2000s

  1. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Nov 8, 2024

    Appco Pharma — Marketing Organization

  2. Nov 12, 2024

    Rubicon Research — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFeb 1, 1967

Chemistry & pharmacology

Loading structure…

SMILES

CCN(CC)CCOc1ccc(C(=C(Cl)c2ccccc2)c2ccccc2)cc1
Mol. weight
405.97 g/mol
Lipinski Ro5
1 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

  • 2-(4-(2-chloro-1,2-diphenylethenyl)phenoxy)-n,n-diethylethanamine
  • 2-(4-(2-chloro-1,2-diphenylethenyl)phenoxy)-n,n-diethylethanamine
  • 2-(p-(2-chloro-1,2-diphenylvinyl)phenoxy)triethylamine
  • 2-(p-(2-chloro-1,2-diphenylvinyl)phenoxy)triethylamine
  • 2-(p-(β-chloro-α-phenylstyryl)phenoxy)triethylamine
  • 2-(p-(β-chloro-α-phenylstyryl)phenoxy)triethylamine
  • androxal
  • androxal
  • chloramiphene
  • chloramiphene
  • cisclomiphene
  • cisclomiphene
  • clomid
  • clomid
  • clomid
  • clomid
  • clomifene
  • clomifene
  • clomifene
  • clomifene
  • clomifene
  • clomifene
  • clomifene citrate
  • clomifene citrate
  • clomifene citrate
  • clomifene citrate
  • clomifene citrate
  • clomifene citrate
  • clomifene citrate
  • clomifeno
  • clomifeno
  • clomifenum
  • clomifenum
  • clomiphencitrat
  • clomiphene
  • clomiphene
  • clomiphene
  • clomiphene
  • clomiphene
  • clomiphene
  • clomiphene b
  • clomiphene citrate
  • clomiphene citrate
  • clomiphene citrate
  • clomiphene citrate
  • clomiphene citrate
  • clophene
  • enclomifene citrate
  • mer-41
  • mer-41
  • milophene
  • milophene
  • mrl-41
  • mrl-41
  • rmi-16289
  • rmi-16289
  • serophene
  • serophene

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06701071Phase 4Dec 31, 2024University of Southern California
NCT06869863Phase 1/Phase 2 (Phase 2)Nov 26, 2024Moscow State University
NCT06635538N/AOct 31, 2024Dexeus Fertility, Fundación Santiago Dexeus Font
NCT06813118Phase 1Jun 7, 2024HITEC-Institute of Medical Sciences
NCT06178523Phase 4Jan 1, 2024Batterjee Medical College
NCT05670795N/AJan 1, 2023Bezmialem University
NCT06564961Phase 3Jul 1, 2022Bangladesh Medical University
NCT05231980Phase 2Jun 5, 2022Ain Shams University, Misr University for Science and Technology
NCT04944836Phase 2Mar 31, 2022University of Utah
NCT06778733Early Phase 1 (Phase 1)Jan 1, 2022Aretaieion University, University of Athens
NCT05096169Phase 2Dec 31, 2021Cornell University
NCT05106712N/ANov 1, 2021Umm Al-Qura University
NCT05089344N/AOct 9, 2021Ain Shams University
NCT05846906Phase 2/Phase 3 (Phase 3)Oct 1, 2021Beni Suef University
NCT04916925Phase 1/Phase 2 (Phase 2)Aug 21, 2021Ain Shams University
NCT05753098Phase 4Jan 15, 2021Beni Suef University
NCT05206448Phase 4Oct 26, 2020American Society for Reproductive Medicine, Society for Reproductive Investigation, University of Iowa, University of Wisconsin
NCT04361175Early Phase 1 (Phase 1)Sep 30, 2020Assiut University
NCT04331197Phase 4May 1, 2020Cairo University
NCT04302532Phase 4Apr 3, 2020Karachi Medical and Dental College
Showing 20 of 146 trials
Page 1 / 8

Organizations

Research & Development (130)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Ain Shams UniversityAcademic/Hospital181852013
Mansoura UniversityAcademic/Hospital111122006
Cairo UniversityAcademic/Hospital9852008
Assiut UniversityAcademic/Hospital8852009
Magna Graecia UniversityAcademic/Hospital6612003
National Institutes of Health (NIH)Government4122002
University of Sao PauloAcademic/Hospital4422004
Beni Suef UniversityAcademic/Hospital3332017
Cornell UniversityAcademic/Hospital3322012
Pennsylvania State UniversityAcademic/Hospital3121991
Royan InstituteAcademic/Hospital3332009
University of Illinois at ChicagoAcademic/Hospital3222015
University of UtahAcademic/Hospital3332010
Yale UniversityAcademic/Hospital3322009
Benha UniversityAcademic/Hospital2212014
FerringFor profit2222005
Fundação de Amparo à Pesquisa do Estado de São PauloAcademic/Hospital2022007
Greenville Health SystemAcademic/Hospital2022008
Menoufia UniversityAcademic/Hospital2112011
Misr University for Science and TechnologyAcademic/Hospital2012018
130 organizations
Page 1 / 7

Marketing (9)

OrganizationOrg typeRelationshipDate
Appco PharmaFor profitMKTGNov 8, 2024
CosetteFor profitMKTGAug 30, 1999
Granata BioFor profitMKTGDec 20, 1988
Merck SeronoFor profitNDA2Mar 22, 1982
Milex Products, IncFor profitMKTGDec 20, 1988
Par PharmaceuticalsFor profitMKTGAug 30, 1999
Rubicon ResearchFor profitMKTGNov 12, 2024
SanofiFor profitNDAFeb 1, 1967
Sanofi-AventisFor profitNDA2Feb 1, 1967