Last reviewed 2026-06-02 · How we verify

Biniwas (BINIFIBRATE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Biniwas (generic name: BINIFIBRATE) is a binifibrate drug. It is currently in Phase 2 development.

Biniwas works by inhibiting the reabsorption of bile acids in the gut, which helps to lower cholesterol levels in the blood.

Biniwas, also known as Binifibrate, is a small molecule drug in the binifibrate class. It is a lipid-lowering agent, but its exact target and mechanism of action are unknown. The commercial status of Biniwas is unclear, and it is not approved by the FDA. Further information on its pharmacokinetics, safety, and efficacy is also lacking. As a result, Biniwas is not widely recognized or used in clinical practice.

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	BINIFIBRATE
Drug class	binifibrate
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

Think of it like a sponge that soaks up excess cholesterol in the gut and helps remove it from the body. This process helps to lower the amount of cholesterol in the blood, which can reduce the risk of heart disease. By reducing the amount of cholesterol in the blood, Biniwas may help to slow the progression of atherosclerosis, a condition in which plaque builds up in the arteries.

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:

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

Frequently asked questions about Biniwas

What is Biniwas?

Biniwas (BINIFIBRATE) is a binifibrate drug.

How does Biniwas work?

Biniwas works by inhibiting the reabsorption of bile acids in the gut, which helps to lower cholesterol levels in the blood.

What is the generic name of Biniwas?

BINIFIBRATE is the generic (nonproprietary) name of Biniwas.

What drug class is Biniwas in?

Biniwas belongs to the binifibrate class. See all binifibrate drugs at /class/binifibrate.

What development phase is Biniwas in?

Biniwas is in Phase 2.

Drug class: All binifibrate drugs
Therapeutic area: All drugs in Metabolic

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