Last reviewed 2026-05-31 · How we verify

Quinestradiol (QUINESTRADOL)

Phase 2 active Small molecule ✓ Verified May 2026

Quinestradiol (generic name: QUINESTRADOL) is a quinestradol drug. It is currently in Phase 2 development.

Quinestradiol works by binding to and activating estrogen receptors, mimicking the effects of estrogen in the body.

Quinestradiol is a small molecule medication. It is also known by the synonyms COLPOVIS, PENTOVIS, and QUINESTRADOL.

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 name	QUINESTRADOL
Drug class	quinestradol
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of estrogen as a key that unlocks certain doors in the body, allowing hormones to flow and cells to grow. Quinestradiol is like a fake key that fits into those same locks, allowing it to influence the body's hormonal balance and potentially treat conditions related to estrogen deficiency.

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:

Quinestradiol CI brief — competitive landscape report
Quinestradiol updates RSS · CI watch RSS

Frequently asked questions about Quinestradiol

What is Quinestradiol?

Quinestradiol (QUINESTRADOL) is a quinestradol drug.

How does Quinestradiol work?

Quinestradiol works by binding to and activating estrogen receptors, mimicking the effects of estrogen in the body.

What is the generic name of Quinestradiol?

QUINESTRADOL is the generic (nonproprietary) name of Quinestradiol.

What drug class is Quinestradiol in?

Quinestradiol belongs to the quinestradol class. See all quinestradol drugs at /class/quinestradol.

What development phase is Quinestradiol in?

Quinestradiol is in Phase 2.

Drug class: All quinestradol drugs
Therapeutic area: All drugs in Other

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