Last reviewed 2026-04-20 · How we verify

Novestrine (METHALLENESTRIL)

Phase 2 active Small molecule

Novestrine (generic name: METHALLENESTRIL) is a methallenestril drug. It is currently in Phase 2 development.

Novestrine works by interacting with a specific biological target to produce a therapeutic effect.

Novestrine, also known as methallenestril, is a small molecule drug of the methallenestril class. Its target and exact mechanism of action are unknown. It is not clear if Novestrine has been approved by the FDA or if it is commercially available. Further information on its commercial status, safety considerations, and pharmacological properties is not available.

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	METHALLENESTRIL
Drug class	methallenestril
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and Novestrine has a key that fits into those locks. When it binds to the lock, it sends a signal that helps to treat a certain medical condition. However, the exact lock and signal it uses are not well understood.

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:

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

Frequently asked questions about Novestrine

What is Novestrine?

Novestrine (METHALLENESTRIL) is a methallenestril drug.

How does Novestrine work?

Novestrine works by interacting with a specific biological target to produce a therapeutic effect.

What is the generic name of Novestrine?

METHALLENESTRIL is the generic (nonproprietary) name of Novestrine.

What drug class is Novestrine in?

Novestrine belongs to the methallenestril class. See all methallenestril drugs at /class/methallenestril.

What development phase is Novestrine in?

Novestrine is in Phase 2.

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

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