Last reviewed 2026-04-19 · How we verify

DROXYPROPINE

Phase 2 active Small molecule

DROXYPROPINE is a droxypropine drug. It is currently in Phase 2 development.

Unfortunately, the mechanism of action of droxypropine is unknown.

Droxypropine is a small molecule drug of the droxypropine class, but its target and mechanism of action are unknown. Its commercial status, including FDA approval, half-life, bioavailability, generic manufacturers, and off-patent status, are also unclear. As a result, there is limited information available on its use, safety, and efficacy. Further research is needed to determine its potential therapeutic applications and key safety considerations. Without more information, it is difficult to provide a comprehensive summary of droxypropine.

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	DROXYPROPINE
Drug class	droxypropine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

This means that we don't know how it works at a molecular level to produce its effects. In general, drugs work by interacting with specific proteins or receptors in the body to alter the way they function. Without more information, it's impossible to say how droxypropine fits into this process.

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:

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

Frequently asked questions about DROXYPROPINE

What is DROXYPROPINE?

DROXYPROPINE is a droxypropine drug.

How does DROXYPROPINE work?

Unfortunately, the mechanism of action of droxypropine is unknown.

What drug class is DROXYPROPINE in?

DROXYPROPINE belongs to the droxypropine class. See all droxypropine drugs at /class/droxypropine.

What development phase is DROXYPROPINE in?

DROXYPROPINE is in Phase 2.

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

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