Last reviewed 2026-04-19 · How we verify

Pravafen

Shionogi · Phase 3 active Small molecule

Pravafen is a Small molecule drug developed by Shionogi. It is currently in Phase 3 development. Also known as: Combination of Pravastatin 40 mg and Fenofibrate 160 mg.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Pravafen
Also known as	Combination of Pravastatin 40 mg and Fenofibrate 160 mg
Sponsor	Shionogi
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia (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:

Pravafen CI brief — competitive landscape report
Pravafen updates RSS · CI watch RSS
Shionogi portfolio CI

Frequently asked questions about Pravafen

What is Pravafen?

Pravafen is a Small molecule drug developed by Shionogi.

Who makes Pravafen?

Pravafen is developed by Shionogi (see full Shionogi pipeline at /company/shionogi).

Is Pravafen also known as anything else?

Pravafen is also known as Combination of Pravastatin 40 mg and Fenofibrate 160 mg.

What development phase is Pravafen in?

Pravafen is in Phase 3.

Manufacturer: Shionogi — full pipeline
Therapeutic area: All drugs in Other
Also known as: Combination of Pravastatin 40 mg and Fenofibrate 160 mg

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