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Mezapam (MEDAZEPAM)

Phase 2 active Small molecule

Mezapam (generic name: MEDAZEPAM) is a medazepam drug. It is currently in Phase 2 development.

Medazepam works by enhancing the calming effect of a neurotransmitter called GABA in the brain.

Medazepam, a small molecule belonging to the drug class of benzodiazepines, is a medication with unknown target and commercial status. Its exact mechanism of action is not well-documented, but it is believed to work by enhancing the effect of the neurotransmitter gamma-aminobutyric acid (GABA) in the brain, leading to sedative, anxiolytic, and muscle relaxant effects. Medazepam is used to treat anxiety and muscle spasms, but its approved indications and pharmacokinetic properties are unknown. As a benzodiazepine, medazepam carries a risk of dependence and withdrawal symptoms, and its use should be carefully monitored. Further research is needed to fully understand the properties and effects of medazepam.

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 nameMEDAZEPAM
Drug classmedazepam
TargetGABA-A receptor; anion channel
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Imagine your brain is like a busy city, with lots of signals and activity going on. GABA is like a traffic cop that helps slow down the traffic and keep things calm. Medazepam helps GABA do its job more effectively, which can lead to feelings of relaxation and reduced anxiety.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Mezapam

What is Mezapam?

Mezapam (MEDAZEPAM) is a medazepam drug.

How does Mezapam work?

Medazepam works by enhancing the calming effect of a neurotransmitter called GABA in the brain.

What is the generic name of Mezapam?

MEDAZEPAM is the generic (nonproprietary) name of Mezapam.

What drug class is Mezapam in?

Mezapam belongs to the medazepam class. See all medazepam drugs at /class/medazepam.

What development phase is Mezapam in?

Mezapam is in Phase 2.

What does Mezapam target?

Mezapam targets GABA-A receptor; anion channel and is a medazepam.

Related

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