Last reviewed 2026-04-20 · How we verify

Oestradiol Undecylate (ESTRADIOL UNDECYLATE)

Phase 2 active Small molecule

Oestradiol Undecylate (generic name: ESTRADIOL UNDECYLATE) is a Estrogen drug. It is currently in Phase 2 development.

Oestradiol Undecylate works by binding to estrogen receptors in the body, influencing various physiological processes.

Oestradiol Undecylate is a small molecule estrogen medication with an unknown target. Its exact mechanism of action is not well-documented, but it is believed to work by binding to estrogen receptors in the body, influencing various physiological processes. The medication's commercial status and approved indications are unknown. As an estrogen medication, it may be used to treat conditions related to estrogen deficiency or imbalance. However, due to the lack of information, its safety profile and potential side effects cannot be fully assessed.

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	ESTRADIOL UNDECYLATE
Drug class	Estrogen
Modality	Small molecule
Therapeutic area	Bone
Phase	Phase 2

Mechanism of action

Imagine your body has locks on cells that only estrogen can open. Oestradiol Undecylate is a key that fits into these locks, allowing estrogen to do its job and influencing things like bone health, skin health, and the menstrual cycle.

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:

Oestradiol Undecylate CI brief — competitive landscape report
Oestradiol Undecylate updates RSS · CI watch RSS

Frequently asked questions about Oestradiol Undecylate

What is Oestradiol Undecylate?

Oestradiol Undecylate (ESTRADIOL UNDECYLATE) is a Estrogen drug.

How does Oestradiol Undecylate work?

Oestradiol Undecylate works by binding to estrogen receptors in the body, influencing various physiological processes.

What is the generic name of Oestradiol Undecylate?

ESTRADIOL UNDECYLATE is the generic (nonproprietary) name of Oestradiol Undecylate.

What drug class is Oestradiol Undecylate in?

Oestradiol Undecylate belongs to the Estrogen class. See all Estrogen drugs at /class/estrogen.

What development phase is Oestradiol Undecylate in?

Oestradiol Undecylate is in Phase 2.

Drug class: All Estrogen drugs
Therapeutic area: All drugs in Bone

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