Last reviewed 2026-05-30 · How we verify

PAPAVEROLINE

Phase 2 active Small molecule ✓ Verified May 2026

PAPAVEROLINE is a papaveroline drug. It is currently in Phase 2 development.

Papaveroline is thought to work by interacting with a specific cellular target, although its exact mechanism of action is not well understood.

Papaveroline is a small molecule drug in the papaveroline class, but its target and mechanism of action are unknown. It is not clear if it is FDA-approved or commercially available. Papaveroline's indications, half-life, bioavailability, generic manufacturers, and patent status are also unknown. As a result, there is limited information available on its safety and efficacy. Further research is needed to understand its potential therapeutic applications.

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	PAPAVEROLINE
Drug class	papaveroline
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine papaveroline as a key that fits into a lock on a cell. When it binds to this lock, it can affect the way the cell functions, potentially leading to changes in the body's response to certain conditions. However, the exact details of how papaveroline interacts with its target are still unclear.

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:

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

Frequently asked questions about PAPAVEROLINE

What is PAPAVEROLINE?

PAPAVEROLINE is a papaveroline drug.

How does PAPAVEROLINE work?

Papaveroline is thought to work by interacting with a specific cellular target, although its exact mechanism of action is not well understood.

What drug class is PAPAVEROLINE in?

PAPAVEROLINE belongs to the papaveroline class. See all papaveroline drugs at /class/papaveroline.

What development phase is PAPAVEROLINE in?

PAPAVEROLINE is in Phase 2.

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

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