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Iomazenil (IOMAZENIL (123I))

Phase 2 active Small molecule

Iomazenil (generic name: IOMAZENIL (123I)) is a iomazenil (123I) drug. It is currently in Phase 2 development.

Iomazenil (123I) works by binding to the benzodiazepine receptor in the brain.

Iomazenil (123I) is a small molecule radiopharmaceutical drug of the iomazenil class. Its exact target is unknown, but it is used in clinical settings. Iomazenil (123I) is not FDA-approved for any indications, and its commercial status, patent status, and availability of generic manufacturers are also unknown. Further research is needed to understand its pharmacokinetic properties, including half-life and bioavailability. As a result, key safety considerations and clinical applications remain unclear.

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 nameIOMAZENIL (123I)
Drug classiomazenil (123I)
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Think of it like a key fitting into a lock. Iomazenil (123I) is a small molecule that binds to a specific receptor in the brain, called the benzodiazepine receptor. This binding can help doctors understand how the brain is working and identify potential problems.

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 Iomazenil

What is Iomazenil?

Iomazenil (IOMAZENIL (123I)) is a iomazenil (123I) drug.

How does Iomazenil work?

Iomazenil (123I) works by binding to the benzodiazepine receptor in the brain.

What is the generic name of Iomazenil?

IOMAZENIL (123I) is the generic (nonproprietary) name of Iomazenil.

What drug class is Iomazenil in?

Iomazenil belongs to the iomazenil (123I) class. See all iomazenil (123I) drugs at /class/iomazenil-123i.

What development phase is Iomazenil in?

Iomazenil is in Phase 2.

Related

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