Last reviewed 2026-05-29 · How we verify

METRALINDOLE

Phase 2 active Small molecule ✓ Verified May 2026

METRALINDOLE is a drug. It is currently in Phase 2 development.

METRALINDOLE is a small molecule that interacts with specific biological pathways to produce its effects.

METRALINDOLE is a small molecule. It is also known by the synonyms METRALINDOL and METRALINDOLE.

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	METRALINDOLE
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and METRALINDOLE is a key that fits into those locks. When it binds to its target, it can either turn the lock on or off, depending on the desired effect. This can help regulate various cellular processes and potentially treat different diseases.

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:

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

Frequently asked questions about METRALINDOLE

What is METRALINDOLE?

METRALINDOLE is a Small molecule drug.

How does METRALINDOLE work?

METRALINDOLE is a small molecule that interacts with specific biological pathways to produce its effects.

What development phase is METRALINDOLE in?

METRALINDOLE is in Phase 2.

Therapeutic area: All drugs in Other

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