Last reviewed 2026-04-20 · How we verify

Ka 2527 (METACLAZEPAM)

Phase 2 active Small molecule Quality 19/100

Ka 2527 (generic name: METACLAZEPAM) is a metaclazepam drug. It is currently in Phase 2 development.

Metaclazepam is thought to work by modulating the activity of neurotransmitters in the brain.

Metaclazepam, a small molecule belonging to the drug class of metaclazepam, is a medication with unknown target and commercial status. Its mechanism of action is not well-documented, and it is not approved by the FDA for any indications. As a result, there is limited information available on its pharmacokinetic properties, such as half-life and bioavailability. Further research is needed to fully understand the properties and potential uses of metaclazepam. Due to the lack of information, it is not possible to provide a comprehensive summary of its safety considerations.

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	METACLAZEPAM
Drug class	metaclazepam
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a busy city with many different streets and intersections. Neurotransmitters are like the traffic signals that help different parts of the brain communicate with each other. Metaclazepam is believed to affect these traffic signals, helping to regulate the flow of information and potentially reducing anxiety or other symptoms.

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:

Ka 2527 CI brief — competitive landscape report
Ka 2527 updates RSS · CI watch RSS

Frequently asked questions about Ka 2527

What is Ka 2527?

Ka 2527 (METACLAZEPAM) is a metaclazepam drug.

How does Ka 2527 work?

Metaclazepam is thought to work by modulating the activity of neurotransmitters in the brain.

What is the generic name of Ka 2527?

METACLAZEPAM is the generic (nonproprietary) name of Ka 2527.

What drug class is Ka 2527 in?

Ka 2527 belongs to the metaclazepam class. See all metaclazepam drugs at /class/metaclazepam.

What development phase is Ka 2527 in?

Ka 2527 is in Phase 2.

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

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