Clomid

(Clomiphene)

ApprovedSmall molecule

Clomiphene is used to help women become pregnant by stimulating the release of eggs from the ovaries. It can also be used in men to treat low testosterone and improve fertility.[2] Clomid is currently approved and in use across 8 indications[4].[1]

Clomid is one of 155 small molecule programs targeting Hypogonadism. It is currently in Approved.

Indications

Total Trials

Active Trials

154

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HypogonadismApproved

Female InfertilityActive, not recruiting

Hypogonadotropic HypogonadismActive, not recruiting

AnovulationApproved

AzoospermiaActive, not recruiting

Polycystic Ovary SyndromeActive, not recruiting

Type 2 DiabetesActive, not recruiting

InfertilityActive, not recruiting

HypogonadismApproved

Approved

Female InfertilityApproved

Active, not recruiting

Hypogonadotropic HypogonadismPhase 2

Active, not recruiting

AnovulationApproved

Approved

AzoospermiaPreclinical

Active, not recruiting

Polycystic Ovary SyndromePreclinical

Active, not recruiting

Type 2 DiabetesPhase 2

Active, not recruiting

InfertilityApproved

Active, not recruiting

Competition

Competitive Landscape

885 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

Clomid

EMD Serono

Approved

1 2

Byetta

AstraZeneca

Preclinical

55 3

Jardiance

Boehringer Ingelheim

Preclinical

31 4

NOVOLIN R

Novo Nordisk

Preclinical

5 5

Cysteine Hydrochloride

Novartis

Preclinical

1 6

Aurlumyn

BBTG International Inc.

Preclinical

1 7

Cecon

MMcGuff Pharmaceuticals, Inc.

Preclinical

1 8

Acipimox

Boehringer Ingelheim

Preclinical

2 9

Blank Control

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Preclinical

1 10

Henagliflozin

TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Preclinical

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

Clinical

Trials by Indication[1]

Polycystic Ovarian Syndrome3 trials

Clomiphene Stair-Step Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome

Completed·—·N/A·NCT01953796·140 enrolled

Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome

Terminated·BBruce Lessey·N/A·NCT01607320·3 enrolled

Letrozole or Combined Clomiphene Citrate Metformin as a First Line Treatment in Women With Polycystic Ovarian Syndrome

Completed·—·N/A·NCT01679574·200 enrolled

Polycystic Ovary Syndrome3 trials

Vitamin D for Polycystic Ovary Syndrome Clomiphene Resistant Women

Completed·—·Phase 4·NCT04010942·120 enrolled

PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene

Completed·UUniversity of Auckland, New Zealand·Phase 4·NCT00795808·171 enrolled

Pulsatile Gonadotropin-releasing Hormone for Infertility in Non-obese Patients With Polycystic Ovary Syndrome

Unknown status·RRenJi Hospital·Phase 4·NCT03989024·78 enrolled

Ovulation2 trials

Use of Clomiphene Citrate as an Inhibitor of Ovulation in an Oocyte Cryopreservation Cycle

Unknown status·NNeil Chappell··NCT05866068·10 enrolled

Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation

Completed·UUniversity of Utah·N/A·NCT01291056·20 enrolled

Endocrinology1 trial

Endocrinology Profile in Patients Undergoing Clomiphene, Letrozole, and Combination Clomiphene and Letrozole Cycles

Withdrawn·UUniversity Hospitals Cleveland Medical Center·N/A·NCT02377479

Infertility1 trial

Combined Letrozole and Clomid in Women With Infertility and PCOS

Completed·RRachel Mejia·Phase 4·NCT02802865·70 enrolled

11 more indications

Hypogonadotropic Hypogonadism1 trial

Hypogonadotropic Hypogonadism in Obese Young Males

Terminated·SSandeep Singh Dhindsa, M.D., F.A.C.E·Phase 2·NCT03245827·9 enrolled

MPA1 trial

A Comparison of Letrozole and Clomifene Citrate

Unknown status·TThe University of Hong Kong·N/A·NCT02647424·40 enrolled

Terminated·SState University of New York at Buffalo·Phase 2·NCT01155518·5 enrolled

Intrauterine Insemination1 trial

Study Evaluating the Timing of Intrauterine Insemination in Relation to Positive Home Ovulation Prediction Kit

Completed·MMidwest Fertility Specialists·N/A·NCT02294773·13 enrolled

Pregnancy1 trial

Pregnancy Rate by HCG Administration Versus Urinary LH Surge Method in Patients Undergoing IUI

Completed·SShiraz University of Medical Sciences·Phase 4·NCT02638285·86 enrolled

Ovarian Stimulation1 trial

Double Ovarian Stimulation as Accumulation Strategy for Older Infertile Patients With Suboptimal Ovarian Response

Unknown status·NNova Clinic, Russia·Phase 4·NCT03400722·120 enrolled

Testosterone1 trial

Clomid in Men With Low Testosterone With and Without Prior Treatment

Completed·PPhoenix VA Health Care System·Phase 2·NCT01904734·42 enrolled

Embryo Transfer1 trial

Letrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer

Unknown status·NNavy General Hospital, Beijing·N/A·NCT02775877·100 enrolled

ILD1 trial

Tamoxifen and Clomiphene Citrate in Mild Stimulation IVF

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 4·NCT02690870·210 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

CLOMID

NDA NDA016131

Mar 22, 1982

SEROPHENE

NDA NDA018361

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Clomiphene. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Clomid drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Clomiphene compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Clomiphene. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA018361). U.S. Food & Drug Administration.
[6]
SEC EDGAR — EMD Serono company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Estrogen Receptor Alpha Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: EMD Serono

Clomid

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Polycystic Ovarian Syndrome3 trials

Polycystic Ovary Syndrome3 trials

Ovulation2 trials

Endocrinology1 trial

Infertility1 trial

Hypogonadotropic Hypogonadism1 trial

MPA1 trial

Azoospermia1 trial

Tics1 trial

Type 2 Diabetes1 trial

Intrauterine Insemination1 trial

Pregnancy1 trial

Ovarian Stimulation1 trial

Testosterone1 trial

Embryo Transfer1 trial

ILD1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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