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Erispan (FLUDIAZEPAM)

Phase 2 active Small molecule

Erispan (generic name: FLUDIAZEPAM) is a fludiazepam drug. It is currently in Phase 2 development.

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

Fludiazepam, also known as Erispan, is a small molecule belonging to the drug class of benzodiazepines. Its mechanism of action involves modulating the activity of neurotransmitters in the brain, specifically enhancing the effect of gamma-aminobutyric acid (GABA), which has a calming effect on the nervous system. However, due to the lack of available information, its target, FDA approval status, and commercial status are unknown. As a result, its approved indications, half-life, bioavailability, and generic manufacturers are also unclear. Further research is necessary to determine the full scope of its use and 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 nameFLUDIAZEPAM
Drug classfludiazepam
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Imagine your brain is like a busy city with many people talking at once. GABA is like a traffic cop that helps calm everyone down and keep the city running smoothly. Fludiazepam helps the traffic cop do its job more effectively, which can lead to a sense 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 Erispan

What is Erispan?

Erispan (FLUDIAZEPAM) is a fludiazepam drug.

How does Erispan work?

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

What is the generic name of Erispan?

FLUDIAZEPAM is the generic (nonproprietary) name of Erispan.

What drug class is Erispan in?

Erispan belongs to the fludiazepam class. See all fludiazepam drugs at /class/fludiazepam.

What development phase is Erispan in?

Erispan is in Phase 2.

Related

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