Last reviewed 2026-06-02 · How we verify

Propentophylline (PROPENTOFYLLINE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Propentophylline (generic name: PROPENTOFYLLINE) is a propentofylline drug. It is currently in Phase 2 development.

Propentofylline works by inhibiting the enzyme acetylcholinesterase, which breaks down the neurotransmitter acetylcholine.

Propentofylline is a small molecule with the synonyms HWA 285, HWA-285, NSC-752424, PROPENTOFILINA, PROPENTOFYLLINE, and PROPENTOFYLLINE.

Likelihood of approval

12.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	PROPENTOFYLLINE
Drug class	propentofylline
Target	Acetylcholinesterase
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of acetylcholine like a messenger in your brain that helps with communication between nerve cells. When acetylcholinesterase breaks it down, the message is lost. By blocking this enzyme, propentofylline allows acetylcholine to stay in the system longer, helping to improve communication between nerve 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:

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

Frequently asked questions about Propentophylline

What is Propentophylline?

Propentophylline (PROPENTOFYLLINE) is a propentofylline drug.

How does Propentophylline work?

Propentofylline works by inhibiting the enzyme acetylcholinesterase, which breaks down the neurotransmitter acetylcholine.

What is the generic name of Propentophylline?

PROPENTOFYLLINE is the generic (nonproprietary) name of Propentophylline.

What drug class is Propentophylline in?

Propentophylline belongs to the propentofylline class. See all propentofylline drugs at /class/propentofylline.

What development phase is Propentophylline in?

Propentophylline is in Phase 2.

What does Propentophylline target?

Propentophylline targets Acetylcholinesterase and is a propentofylline.

Drug class: All propentofylline drugs
Target: All drugs targeting Acetylcholinesterase
Therapeutic area: All drugs in Neuroscience

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