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Octestrol (BENZESTROL)

Phase 2 active Small molecule ✓ Verified May 2026

Octestrol (generic name: BENZESTROL) is a benzestrol drug. It is currently in Phase 2 development.

Benzestrol is thought to work by binding to estrogen receptors, mimicking the effects of estrogen in the body.

Octestrol, also known as Benzestrol, is a small molecule drug in the benzestrol class. Its exact target and mechanism of action are unknown, and it has not been approved by the FDA for any indications. As a result, there is limited information available on its commercial status, safety considerations, or pharmacokinetic properties. Further research is needed to fully understand the potential benefits and risks of this compound. Due to its lack of FDA approval and limited information, it is not currently available as a prescription medication.

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 nameBENZESTROL
Drug classbenzestrol
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Imagine your body has locks on the door of cells that only estrogen can open. Benzestrol is a key that fits into those locks, allowing it to enter the cell and trigger a response. This can affect various bodily functions, but the exact details of how it works are still unclear.

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 Octestrol

What is Octestrol?

Octestrol (BENZESTROL) is a benzestrol drug.

How does Octestrol work?

Benzestrol is thought to work by binding to estrogen receptors, mimicking the effects of estrogen in the body.

What is the generic name of Octestrol?

BENZESTROL is the generic (nonproprietary) name of Octestrol.

What drug class is Octestrol in?

Octestrol belongs to the benzestrol class. See all benzestrol drugs at /class/benzestrol.

What development phase is Octestrol in?

Octestrol is in Phase 2.

Related

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