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CLOMIPHENE
Clomiphene is a marketed drug primarily indicated for ovulatory dysfunction, holding a significant position in the fertility treatment market. Its key strength lies in its well-established mechanism and long-term use, supported by a key composition patent expiring in 2028. The primary risk is the potential increase in competition as the patent expiration approaches, which could erode market share and revenue.
At a glance
| Generic name | CLOMIPHENE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1967 |
Approved indications
- Ovulatory Dysfunction
- Polycystic Ovary Syndrome
- Amenorrhea-Galactorrhea Syndrome
- Psychogenic Amenorrhea
- Post-Oral-Contraceptive Amenorrhea
- Secondary Amenorrhea of Undetermined Etiology
Common side effects
- Ovarian Enlargement
- Vasomotor Flushes
- Abdominal-Pelvic Discomfort/Distention/Bloating
- Nausea and Vomiting
- Breast Discomfort
- Visual Symptoms Blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes
- Headache
- Abnormal Uterine Bleeding Intermenstrual spotting, menorrhagia
Drug interactions
- clomiphene citrate
Key clinical trials
- FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea (PHASE3)
- INTEnsity of ovariaN Stimulation and Embryo Quality (PHASE4)
- Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial (PHASE2)
- Effect Clomiphene vs Clomiphene Along With Pioglitazone on Ovarian Stimulation Rate (PHASE4)
- The Effect Of Polycystic Ovarian Syndrome Treatment On Ocular Surface.
- The Effect of Therapy Combination in PCOS With Dlbs 3233 (EARLY_PHASE1)
- Vaginal Estradiol and Oral Guaifenesin in Clomiphene Ovulation Induction (NA)
- Ovarian Hyperstimulation and Fibrin Clot Properties. (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CLOMIPHENE CI brief — competitive landscape report
- CLOMIPHENE updates RSS · CI watch RSS