Last reviewed 2026-05-30 · How we verify

FEPRADINOL

Phase 2 active Small molecule ✓ Verified May 2026

FEPRADINOL is a fepradinol drug. It is currently in Phase 2 development.

FEPRADINOL is thought to work by interacting with specific biological targets to produce its therapeutic effects.

FEPRADINOL is a small molecule. Its exact function and indications are not specified in the provided information.

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	FEPRADINOL
Drug class	fepradinol
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and FEPRADINOL is a key that fits into those locks. When it binds to the locks, it can either block or enhance the activity of the cells, depending on the specific target. This can help to treat various conditions by modulating the activity of the cells.

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:

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

Frequently asked questions about FEPRADINOL

What is FEPRADINOL?

FEPRADINOL is a fepradinol drug.

How does FEPRADINOL work?

FEPRADINOL is thought to work by interacting with specific biological targets to produce its therapeutic effects.

What drug class is FEPRADINOL in?

FEPRADINOL belongs to the fepradinol class. See all fepradinol drugs at /class/fepradinol.

What development phase is FEPRADINOL in?

FEPRADINOL is in Phase 2.

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

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