phenobarbital
Trade name: Luminal
Small moleculeapprovedOrphan Drug FDAFast Track FDA
Approved
Nov 17, 2022
Phenobarbital, also known as phenobarbitone or phenobarb, sold under the brand name Luminal among others, is a medication of the barbiturate type. It is recommended by the World Health Organization (WHO) for the treatment of certain types of epilepsy in developing countries. In the developed world, it is commonly used to treat seizures in young children, while other medications are generally used in older children and adults. It is also used for veterinary purposes. — Wikipedia
Clinical trial activity
33 trials · 58 clinical orgs · 2 marketing orgs
Phase 1
3
Phase 2
15
Phase 3
11
Phase 4
9
Earliest trial started Feb 1, 1993 (NCT00009620)
Timeline
1910s
- Jan 1, 1912
Evidence of US Marketing
2010s
- Jan 1, 2017
Earliest Phase 2 Sponsor(trial)
- Oct 2, 2019
Orphan Drug Designation
2020s
- Nov 17, 2022
Sun Pharmaceuticals — Earliest FDA Approval
- Nov 17, 2022
SPARC — Marketing Organization
- Nov 17, 2022
Sun Pharmaceuticals — Marketing Organization
- Nov 17, 2022
Sun Pharmaceuticals — NDA Secondary Org
- Nov 17, 2022
Sun Pharmaceuticals — NDA Organization
Indications
Approved for
Studied for
- Acute Febrile Encephalopathy · Phase 2
- Acute Kidney Injury · Phase 4
- Alcohol Withdrawal Delirium · Phase 4
- Analgesics, Opioid · Phase 3
- Anxiety Disorders · Phase 3
- Astrocytoma · Phase 1
- Brain Injuries · Phase 4
- Brain Injuries, Traumatic · Phase 4
- Brain Ischemia · Phase 4
- Coma · Phase 4
- Dementia · Phase 3
- Depression · Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 1
- Drug Resistant Epilepsy · Phase 4
- Epilepsy, Benign Neonatal · Phase 3
- Glioblastoma · Phase 1
- Glioma · Phase 4
- Gliosarcoma · Phase 1
- Heart Arrest · Phase 4
- Hypoxia, Brain · Phase 4
- Hypoxia-Ischemia, Brain · Phase 4
- Infant, Low Birth Weight · Phase 3
- Infant, Newborn · Phase 3
- Infant, Premature · Phase 3
- Infant, Small for Gestational Age · Phase 3
- Intestinal Neoplasms · Phase 1
- Intracranial Hemorrhages · Phase 4
- Lymphoma · Phase 1
- Neonatal Abstinence Syndrome · Phase 3
- Neoplasms · Phase 1
- Neutropenia · Phase 1
- Oligodendroglioma · Phase 1
- Pediatrics · Phase 3
- Persistent Vegetative State · Phase 4
- Pharmacokinetics · Phase 4
- Psychophysiologic Disorders · Phase 3
- Renal Insufficiency · Phase 4
- Schizophrenia · Phase 3
- Seizures · Phase 4
- Status Epilepticus · Phase 3
- Stroke · Phase 4
Mechanism of action
- GABA-A receptorALLOSTERIC ANTAGONIST
GABA-A receptor allosteric antagonist
Approval history
- approvedPriority reviewFast trackNov 17, 2022
- approvedPriority reviewFast trackJan 1, 1912
Chemistry & pharmacology
Loading structure…
SMILES
CCC1(c2ccccc2)C(=O)NC(=O)NC1=O- Mol. weight
- 232.24 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- ChEMBLCHEMBL40 ↗
- WikipediaPhenobarbital ↗
- ChEMBLCHEMBL3707233 ↗
- ChEMBLCHEMBL149972 ↗
Also known as
- 5-ethyl-5-phenyl-2,4,6(1h,3h,5h)-pyrimidinetrione
- 5-ethyl-5-phenyl-2,4,6(1h,3h,5h)-pyrimidinetrione
- 5-ethyl-5-phenylbarbituric acid
- 5-ethyl-5-phenylbarbituric acid
- 5-ethyl-5-phenylpyrimidine-2,4,6(1h,3h,5h)-trione
- 5-ethyl-5-phenylpyrimidine-2,4,6(1h,3h,5h)-trione
- 5-ethyl-5-phenyl-pyrimidine-2,4,6-trione
- 5-ethyl-5-phenyl-pyrimidine-2,4,6-trione
- 5-phenyl-5-ethylbarbituric acid
- 5-phenyl-5-ethylbarbituric acid
- adonal
- dormiral
- eskabarb
- eskabarb
- gardenal sod
- luminal
- luminal
- luminal sodium
- luminal sodium
- neurobarb
- noptil
- noptil
- phenaemal
- phenemal
- phenemal
- phenobarbital
- phenobarbital
- phenobarbital
- phenobarbital
- phenobarbital
- phenobarbital
- phenobarbital
- phenobarbital
- phenobarbital
- phenobarbital sod
- phenobarbital sod
- phenobarbital sodium
- phenobarbital sodium
- phenobarbital sodium
- phenobarbitol
- phenobarbitol
- phenobarbitol
- phenobarbitone
- phenobarbitone
- phenobarbitone
- phenobarbitone
- phenobarbitone
- phenobarbitone
- phenobarbitone
- phenobarbituric acid
- phenobarbituric acid
- phenylaethylbarbitursaeure
- phenylaethylbarbitursaeure
- phenylethylbarbiturate
- phenylethylbarbiturate
- phenylethylbarbituric acid
- phenylethylbarbituric acid
- phenylethylbarbitursaeure
- phenylethylbarbitursaeure
- phenylethylmalonylurea
- phenylethylmalonylurea
- phenylethylmalonylurea
- sedophen
- sodium phenobarbital
- sodium phenobarbital
- solfoton
- solfoton
- talpheno
- talpheno
- versomnal
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07284498 | Phase 4 | Jan 1, 2026 | Mansoura University |
| NCT07098728 | N/A | Jul 22, 2025 | Government of Myanmar |
| NCT06081283 | Phase 4 | Nov 20, 2023 | University of North Carolina at Chapel Hill |
| NCT05610085 | Phase 2 | Jan 1, 2023 | Middlemore Hospital, New Zealand, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, University of Auckland, University of California, San Diego, University of Minnesota |
| NCT05346666 | Phase 3 | Jun 25, 2022 | Damanhour University, Horus University, Tanta University |
| NCT05291455 | Phase 3 | Mar 1, 2022 | Kafrelsheikh University, Tanta University |
| NCT04650204 | Phase 4 | Dec 15, 2020 | Mayo Clinic, National Cancer Institute (NCI) |
| NCT04320940 | Phase 3 | Jul 1, 2020 | Hikma, Nema Research |
| NCT04156464 | Phase 4 | Dec 1, 2019 | OSF HealthCare |
| NCT03788889 | Phase 4 | Jun 1, 2019 | Santa Barbara Cottage Hospital |
| NCT03670160 | Phase 2 | Oct 1, 2018 | University of Tennessee |
| NCT03602118 | Phase 3 | Oct 1, 2018 | PharPoint Research, Inc. |
| NCT03586089 | N/A | Sep 30, 2018 | University of Toronto |
| NCT03632915 | Phase 4 | Nov 20, 2017 | University of Maryland |
| NCT03107507 | Phase 4 | Mar 25, 2017 | Cairo University |
| NCT03025906 | Phase 2 | Feb 1, 2017 | Capital Medical University |
| NCT02550028 | Phase 4 | Sep 1, 2015 | Fudan University, Guangxi Medical University, Guangzhou Medical University, Maternal and Child Health Hospital of Hubei Province, Wenzhou Medical University, Xiamen University |
| NCT03650270 | Phase 3 | Mar 1, 2015 | University of Cape Town |
| NCT02374567 | Phase 3 | Jan 1, 2015 | Gottfried Wilhelm Leibniz Universität Hannover |
| NCT02726867 | Phase 3 | Feb 1, 2014 | Mid-Atlantic Epilepsy and Sleep Center |
Showing 20 of 33 trials
Page 1 / 2
Organizations
Research & Development (58)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 2 | 1 | 2 | 1996 |
| Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA | Academic/Hospital | 2 | 0 | 1 | 2013 |
| Tanta University | Academic/Hospital | 2 | 1 | 1 | 2022 |
| University of Auckland | Academic/Hospital | 2 | 0 | 1 | 2013 |
| University of California, San Diego | Academic/Hospital | 2 | 2 | 1 | 2013 |
| University of Tennessee | Academic/Hospital | 2 | 1 | 2 | 1993 |
| Alameda County Medical Center | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Bristol-Myers Squibb | For profit | 1 | 0 | 1 | 2009 |
| Brown University | Academic/Hospital | 1 | 0 | 1 | 1993 |
| Cairo University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Capital Medical University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Case Western Reserve University | Academic/Hospital | 1 | 0 | 1 | 1993 |
| Damanhour University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Duke University | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Emory University | Academic/Hospital | 1 | 0 | 1 | 1993 |
| Fudan University | Academic/Hospital | 1 | 1 | 1 | 2015 |
| George Washington University | Academic/Hospital | 1 | 0 | 1 | 1993 |
| Gottfried Wilhelm Leibniz Universität Hannover | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Government of Myanmar | Government | 1 | 1 | 1 | 2025 |
| Guangxi Medical University | Academic/Hospital | 1 | 0 | 1 | 2015 |
58 organizations
Page 1 / 3
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| SPARC | For profit | MKTG | Nov 17, 2022 |
| Sun Pharmaceuticals | For profit | MKTG | Nov 17, 2022 |
| Sun Pharmaceuticals | For profit | NDA2 | Nov 17, 2022 |
| Sun Pharmaceuticals | For profit | NDA | Nov 17, 2022 |