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Gerodorm (CINOLAZEPAM)

Phase 2 active Small molecule ✓ Verified May 2026 Quality 29/100

Gerodorm (generic name: CINOLAZEPAM) is a cinolazepam drug. It is currently in Phase 2 development.

Cinolazepam is a benzodiazepine receptor agonist that enhances the activity of the neurotransmitter gamma-aminobutyric acid (GABA) to produce a calming effect.

Gerodorm is a small molecule modality. It is also known by the synonyms CINOLAZEPAM and GERODORM.

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 nameCINOLAZEPAM
Drug classcinolazepam
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Imagine your brain is like a busy city with lots of people talking and moving around. GABA is like a traffic cop that helps calm things down and slow traffic. Cinolazepam works by helping the traffic cop do its job more effectively, which can help reduce anxiety and promote relaxation.

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:

Frequently asked questions about Gerodorm

What is Gerodorm?

Gerodorm (CINOLAZEPAM) is a cinolazepam drug.

How does Gerodorm work?

Cinolazepam is a benzodiazepine receptor agonist that enhances the activity of the neurotransmitter gamma-aminobutyric acid (GABA) to produce a calming effect.

What is the generic name of Gerodorm?

CINOLAZEPAM is the generic (nonproprietary) name of Gerodorm.

What drug class is Gerodorm in?

Gerodorm belongs to the cinolazepam class. See all cinolazepam drugs at /class/cinolazepam.

What development phase is Gerodorm in?

Gerodorm is in Phase 2.

Related

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