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Thiodrol (EPITIOSTANOL)

Phase 2 active Small molecule

Thiodrol (generic name: EPITIOSTANOL) is a drug. It is currently in Phase 2 development.

Thiodrol works by inhibiting the conversion of testosterone to dihydrotestosterone (DHT), a potent form of testosterone.

Thiodrol, also known as Epitiostanol, is a small molecule modality with unknown drug class and target. Its commercial status is unclear, and it is not FDA approved for any indications. As a result, there is limited information available on its pharmacokinetic properties, such as half-life and bioavailability. Further research is needed to determine its efficacy and safety profile. It is currently owned by an unknown entity.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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).
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameEPITIOSTANOL
ModalitySmall molecule
Therapeutic areaUrology
PhasePhase 2

Mechanism of action

Think of it like a traffic cop: Thiodrol blocks the road that leads to DHT, a hormone that can contribute to conditions like prostate enlargement and hair loss. By reducing DHT levels, Thiodrol may help alleviate symptoms associated with these conditions. This is a simplified explanation of a complex biochemical process.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Thiodrol

What is Thiodrol?

Thiodrol (EPITIOSTANOL) is a Small molecule drug.

How does Thiodrol work?

Thiodrol works by inhibiting the conversion of testosterone to dihydrotestosterone (DHT), a potent form of testosterone.

What is the generic name of Thiodrol?

EPITIOSTANOL is the generic (nonproprietary) name of Thiodrol.

What development phase is Thiodrol in?

Thiodrol is in Phase 2.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing