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phenobarbitone

Institute of Child Health · Phase 1 active Small molecule ✓ Verified May 2026

phenobarbitone is a Small molecule drug developed by Institute of Child Health. It is currently in Phase 1 development for Bipolar disorder in remission, Cluster Headache Prevention, Cluster headache syndrome.

Phenobarbitone, also known as phenobarbital, is a medication of the barbiturate type used to treat certain types of epilepsy, including in young children. It is also recommended by the World Health Organization for the treatment of epilepsy in developing countries.

Likelihood of approval
6.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% 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 2033–2036 —
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +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 namephenobarbitone
SponsorInstitute of Child Health
TargetNuclear receptor subfamily 1 group I member 2, Nuclear receptor subfamily 1 group I member 3, GABA-A receptor alpha-1/beta-2/gamma-2
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 1

Approved indications

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 phenobarbitone

What is phenobarbitone?

phenobarbitone is a Small molecule drug developed by Institute of Child Health, indicated for Bipolar disorder in remission, Cluster Headache Prevention, Cluster headache syndrome.

What is phenobarbitone used for?

phenobarbitone is indicated for Bipolar disorder in remission, Cluster Headache Prevention, Cluster headache syndrome, Epilepsy, Epilepsy characterized by intractable complex partial seizures.

Who makes phenobarbitone?

phenobarbitone is developed by Institute of Child Health (see full Institute of Child Health pipeline at /company/institute-of-child-health).

What development phase is phenobarbitone in?

phenobarbitone is in Phase 1.

What does phenobarbitone target?

phenobarbitone targets Nuclear receptor subfamily 1 group I member 2, Nuclear receptor subfamily 1 group I member 3, GABA-A receptor alpha-1/beta-2/gamma-2.

Related

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