Last reviewed 2026-05-26 · How we verify

Hydramitrazine (MELADRAZINE)

Phase 2 active Small molecule ✓ Verified May 2026

Hydramitrazine (generic name: MELADRAZINE) is a meladrazine drug. It is currently in Phase 2 development.

Hydramitrazine is thought to work by interacting with biological pathways, but the exact mechanism is unknown.

Hydramitrazine is a small molecule with the synonyms BA 13155 FREE BASE, BA-13155 FREE BASE, HYDRAMITRAZINE, MELADRAZINA, MELADRAZINE, and MELADRAZINE.

Likelihood of approval

12.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	MELADRAZINE
Drug class	meladrazine
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like a city with many different roads and intersections. Hydramitrazine is like a traffic controller that tries to regulate the flow of traffic, but we don't know exactly how it does it or which roads it's controlling. This means we don't fully understand how it affects the body or what potential side effects it might have.

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:

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

Frequently asked questions about Hydramitrazine

What is Hydramitrazine?

Hydramitrazine (MELADRAZINE) is a meladrazine drug.

How does Hydramitrazine work?

Hydramitrazine is thought to work by interacting with biological pathways, but the exact mechanism is unknown.

What is the generic name of Hydramitrazine?

MELADRAZINE is the generic (nonproprietary) name of Hydramitrazine.

What drug class is Hydramitrazine in?

Hydramitrazine belongs to the meladrazine class. See all meladrazine drugs at /class/meladrazine.

What development phase is Hydramitrazine in?

Hydramitrazine is in Phase 2.

Drug class: All meladrazine drugs
Therapeutic area: All drugs in Neuroscience

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