Last reviewed · How we verify
Androxal 25 mg
Androxal 25 mg is a Small molecule drug developed by Repros Therapeutics Inc.. It is currently in Phase 1 development. Also known as: enclomiphene citrate.
Androxal 25 mg is a small molecule used in clinical trials for conditions such as secondary hypogonadism and subfertility. It has been studied in a randomized, double-blind, placebo and active-controlled, parallel, multi-center Phase IIb study to evaluate normalization of morning testosterone levels in men with secondary hypogonadism.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 25 mg |
|---|---|
| Also known as | enclomiphene citrate |
| Sponsor | Repros Therapeutics Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Upper respiratory tract infection
- Abdominal hernia
- Umbilical hernia
- Coxsackie viral infection
- Gastroenteritis viral
- Influenza
- Viral pharyngitis
- Fall
- Rib fracture
- Wrist fracture
- Electrocardiogram abnormal
- Haematocrit increased
Key clinical trials
- Cost-effective Treatment of Unexplained Infertility (PHASE4)
- Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate (PHASE2)
- Dual Ovarian Stimulation (Duostim) and Shanghai Protocols in Poor Ovarian Responders (PHASE3)
- Mild Stimulation Protocol Using Clomiphene Citrate for Women With PCOS Undergoing in Vitro Fertilization (PHASE4)
- Clomid in Men With Low Testosterone With and Without Prior Treatment (PHASE2)
- Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study) (NA)
- Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate (PHASE2, PHASE3)
- Androxal in Male Infertility (PHASE2, PHASE3)
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 25 mg CI brief — competitive landscape report
- Androxal 25 mg updates RSS · CI watch RSS
- Repros Therapeutics Inc. portfolio CI
Frequently asked questions about Androxal 25 mg
What is Androxal 25 mg?
Who makes Androxal 25 mg?
Is Androxal 25 mg also known as anything else?
What development phase is Androxal 25 mg in?
What are the side effects of Androxal 25 mg?
Related
- Manufacturer: Repros Therapeutics Inc. — full pipeline
- Also known as: enclomiphene citrate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing