Last reviewed 2026-05-31 · How we verify

Biliodyl (PHENOBUTIODIL)

Phase 2 active Small molecule ✓ Verified May 2026

Biliodyl (generic name: PHENOBUTIODIL) is a phenobutiodil drug. It is currently in Phase 2 development.

Biliodyl is thought to work by interacting with a specific biological target, although the exact nature of this interaction is not well understood.

Biliodyl, also known as PHENOBUTIODIL, is a small molecule drug in the phenobutiodil class. Its exact target and mechanism of action are unknown, and it has not been approved by the FDA for any indications. The commercial status of Biliodyl is unclear, with no information available on its patent status or generic manufacturers. Further research is needed to determine the safety and efficacy of this compound. As a result, it is not currently available for clinical use.

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	PHENOBUTIODIL
Drug class	phenobutiodil
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and Biliodyl is a key that fits into one of those locks. When it binds to the lock, it can either turn it on or off, depending on the type of lock and the key's shape. This can help regulate various bodily functions, but more research is needed to understand how Biliodyl works and what effects it has on the body.

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:

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

Frequently asked questions about Biliodyl

What is Biliodyl?

Biliodyl (PHENOBUTIODIL) is a phenobutiodil drug.

How does Biliodyl work?

Biliodyl is thought to work by interacting with a specific biological target, although the exact nature of this interaction is not well understood.

What is the generic name of Biliodyl?

PHENOBUTIODIL is the generic (nonproprietary) name of Biliodyl.

What drug class is Biliodyl in?

Biliodyl belongs to the phenobutiodil class. See all phenobutiodil drugs at /class/phenobutiodil.

What development phase is Biliodyl in?

Biliodyl is in Phase 2.

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

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