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Anamidol (OXYMESTERONE)
Anamidol (generic name: OXYMESTERONE) is a oxymesterone drug. It is currently in Phase 2 development for Bilateral Anorchia, Congenital myotonia, autosomal dominant form, Deficiency of testosterone biosynthesis.
Anamidol binds to androgen receptors in the body, triggering a cascade of downstream effects that promote muscle growth and development.
There is limited information available on Anamidol's modality, as it is listed as "Unknown" on ChEMBL.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | OXYMESTERONE |
|---|---|
| Drug class | oxymesterone |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Think of it like a key fitting into a lock. Anamidol is the key that fits into androgen receptors, which are like locks on cells throughout the body. When the key fits into the lock, it sends a signal that tells the cell to start building muscle and other male characteristics.
Approved indications
- Bilateral Anorchia
- Congenital myotonia, autosomal dominant form
- Deficiency of testosterone biosynthesis
- Delayed puberty
- Hormone receptor positive malignant neoplasm of breast
- Klinefelter's syndrome, XXY
- LHRH Deficiency
- Male hypogonadism
- Noonan's syndrome
- Primary Hypogonadism due to Bilateral Torsion
- Primary Hypogonadism due to Orchitis
- Undescended testicle
Common side effects
Key clinical trials
- Body Composition Assessment in Transgender Population.
- Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening (PHASE4)
- Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism (PHASE2)
- Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC (PHASE2)
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (PHASE2)
- Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? (PHASE2,PHASE3)
- Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance (PHASE4)
- Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer (PHASE1)
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:
- Anamidol CI brief — competitive landscape report
- Anamidol updates RSS · CI watch RSS
Frequently asked questions about Anamidol
What is Anamidol?
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Related
- Drug class: All oxymesterone drugs
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Bilateral Anorchia
- Indication: Drugs for Congenital myotonia, autosomal dominant form
- Indication: Drugs for Deficiency of testosterone biosynthesis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing