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Androxal
Androxal is a Small molecule drug developed by Repros Therapeutics Inc.. It is currently in Phase 3 development. Also known as: enclomiphene citrate, Enclomiphene citrate.
Androxal, also known as enclomifene, is a small molecule that acts as a selective estrogen receptor modulator. It is used as an adjuvant to clomiphene citrate for the management of unexplained infertility, as seen in a randomized controlled trial (NCT03549741) conducted at Assiut University.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Androxal |
|---|---|
| Also known as | enclomiphene citrate, Enclomiphene citrate |
| Sponsor | Repros Therapeutics Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
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 |
|---|---|
| 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:
- Androxal CI brief — competitive landscape report
- Androxal updates RSS · CI watch RSS
- Repros Therapeutics Inc. portfolio CI
Frequently asked questions about Androxal
What is Androxal?
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Is Androxal also known as anything else?
What development phase is Androxal in?
Related
- Manufacturer: Repros Therapeutics Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: enclomiphene citrate, Enclomiphene citrate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing