Last reviewed 2026-05-30 · How we verify

Metebanyl (DROTEBANOL)

Phase 2 active Small molecule ✓ Verified May 2026

Metebanyl (generic name: DROTEBANOL) is a drug. It is currently in Phase 2 development.

Metebanyl works by binding to specific biological molecules to produce its effects.

Metebanyl is a small molecule with the synonyms Drotebanol, IDS-ND-018, and Oxymetebanol.

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	DROTEBANOL
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and Metebanyl is a key that fits into those locks. When it binds to the right lock, it can turn on or off certain cellular processes, which can help treat a variety of diseases. However, the exact lock that Metebanyl fits into is still unknown, and more research is needed to understand how it works.

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:

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

Frequently asked questions about Metebanyl

What is Metebanyl?

Metebanyl (DROTEBANOL) is a Small molecule drug.

How does Metebanyl work?

Metebanyl works by binding to specific biological molecules to produce its effects.

What is the generic name of Metebanyl?

DROTEBANOL is the generic (nonproprietary) name of Metebanyl.

What development phase is Metebanyl in?

Metebanyl is in Phase 2.

Therapeutic area: All drugs in Other

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