Last reviewed 2026-05-30 · How we verify

MECLOXAMINE

Phase 2 active Small molecule ✓ Verified May 2026

MECLOXAMINE is a mecloxamine drug. It is currently in Phase 2 development.

Meclozamine is thought to work by interacting with a specific molecular target to produce its therapeutic effects.

Meclozamine is a small molecule. It is also known by the synonyms Meclozamina and Meclozamine.

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	MECLOXAMINE
Drug class	mecloxamine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and meclozamine is a key that fits into those locks. When it binds to the lock, it can either open the lock to allow something beneficial to enter the cell or block the lock to prevent something harmful from entering. This interaction can help to treat various conditions by altering the way cells function.

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:

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

Frequently asked questions about MECLOXAMINE

What is MECLOXAMINE?

MECLOXAMINE is a mecloxamine drug.

How does MECLOXAMINE work?

Meclozamine is thought to work by interacting with a specific molecular target to produce its therapeutic effects.

What drug class is MECLOXAMINE in?

MECLOXAMINE belongs to the mecloxamine class. See all mecloxamine drugs at /class/mecloxamine.

What development phase is MECLOXAMINE in?

MECLOXAMINE is in Phase 2.

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

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