Last reviewed 2026-05-14 · How we verify

FENPIVERINIUM

Phase 2 active Small molecule

FENPIVERINIUM is a fenpiverinium drug. It is currently in Phase 2 development.

Fenpiverinium works by interacting with a specific target in the body to produce a therapeutic effect.

Fenpiverinium is a small molecule drug in the fenpiverinium class, but its target and exact mechanism of action are unknown. It is not clear if it has been approved by the FDA or if it is patented or off-patent. There is limited information available on its pharmacokinetic properties, such as half-life and bioavailability. Further research is needed to understand its clinical use and safety profile. As a result, it is not possible to provide a comprehensive summary of its commercial status or key safety considerations.

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	FENPIVERINIUM
Drug class	fenpiverinium
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Unfortunately, the exact way fenpiverinium works is not well understood, but it is thought to affect the body's response to certain stimuli. This can lead to changes in how the body functions, which can be beneficial for treating certain conditions. However, more research is needed to fully understand its mechanism of action.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Efficacy and Safety Study of Ketorolac / Pitofenone / Fenpiverinium for the Treatment of Patients With Pain After Surgical Abdominal and Pelvic Operations (PHASE2,PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

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

Frequently asked questions about FENPIVERINIUM

What is FENPIVERINIUM?

FENPIVERINIUM is a fenpiverinium drug.

How does FENPIVERINIUM work?

Fenpiverinium works by interacting with a specific target in the body to produce a therapeutic effect.

What drug class is FENPIVERINIUM in?

FENPIVERINIUM belongs to the fenpiverinium class. See all fenpiverinium drugs at /class/fenpiverinium.

What development phase is FENPIVERINIUM in?

FENPIVERINIUM is in Phase 2.

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

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