Last reviewed 2026-04-20 · How we verify

Fenpyramine (MILVERINE)

Phase 2 active Small molecule

Fenpyramine (generic name: MILVERINE) is a milverine drug. It is currently in Phase 2 development.

Fenpyramine is believed to affect the body's response to pain, although its exact mechanism of action is unknown.

Fenpyramine, also known as Milverine, is a small molecule drug in the milverine class. Its target and exact mechanism of action are unknown, but it is believed to work by affecting the body's response to pain. Fenpyramine is not FDA-approved for any indications, and its commercial status, patent status, and availability of generic manufacturers are also unknown. As a result, there is limited information available on its safety profile and efficacy. Further research is needed to fully understand the properties and potential uses of Fenpyramine.

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	MILVERINE
Drug class	milverine
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your body has a system that helps you feel pain. Fenpyramine is thought to interact with this system in some way, but we don't know exactly how. This interaction may help reduce the amount of pain you feel.

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:

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

Frequently asked questions about Fenpyramine

What is Fenpyramine?

Fenpyramine (MILVERINE) is a milverine drug.

How does Fenpyramine work?

Fenpyramine is believed to affect the body's response to pain, although its exact mechanism of action is unknown.

What is the generic name of Fenpyramine?

MILVERINE is the generic (nonproprietary) name of Fenpyramine.

What drug class is Fenpyramine in?

Fenpyramine belongs to the milverine class. See all milverine drugs at /class/milverine.

What development phase is Fenpyramine in?

Fenpyramine is in Phase 2.

Drug class: All milverine drugs
Therapeutic area: All drugs in Pain

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