pemoline

Trade name: cylert

Small moleculeapproved

Approved

Jan 27, 1975

Pemoline is a central nervous system stimulant. Pemoline is structurally dissimilar to the amphetamines and methylphenidate. Pemoline is generally considered dopaminergic, but its precise method of action hasn't yet been definitively determined. The interaction of pemoline with other drugs has not been studied in humans. The following are adverse reactions in decreasing order of severity within each category associated with pemoline: hepatic dysfunction, aplastic anemia, convulsive seizures, hallucinations, insomnia, anorexia and weight loss. — NCATS

Clinical trial activity

2 trials · 4 clinical orgs · 8 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Sep 1, 1994 (NCT00000282)

Timeline

1970s

Jan 27, 1975
Abbott — Earliest FDA Approval
Jan 27, 1975
Abbott — NDA Organization

1990s

Jan 1, 1994
Earliest Phase 2 Sponsor(trial)
Jan 29, 1999
Teva — Marketing Organization
Jun 30, 1999
Fosun — Marketing Organization

2000s

Feb 28, 2000
Actavis — Marketing Organization
Apr 19, 2000
Vintage — Marketing Organization
Sep 18, 2000
Watson Pharmaceuticals — Marketing Organization
Mar 30, 2001
Mallinckrodt — Marketing Organization
Mar 30, 2001
International Minerals and Chemical Corporation — Marketing Organization

Indications

Approved for

Studied for

Cocaine-Related Disorders · Phase 2

Mechanism of action

Unspecified targetOTHER
Unknown

Approval history

approvedPriority reviewJan 27, 1975

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC(=O)C(O1)C2=CC=CC=C2

Mol. weight: 176.172 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Racemic Mixture
Inorganic: No
Polymer: No
Delivery: Oral

Oral

Yes

Parenteral

Topical

Black box warning

Sources

Also known as

azoksodon
azoxodon
azoxodone
centramin
cylert
cylert
cylert
dantromin
fenoxazol
fenoxazol
fenoxazol
magnesium pemoline
pemolin
pemoline
pemoline
pemoline
pemoline
pemoline
pemoline
pemoline
pemoline
pemoline
pemoline
pemoline
pemoline hcl
pemoline hydrochloride
pheniminooxazolidino
phenoxazole
phenylisohydantoin
phenylpseudohydantoi
ronyl
ronyl
tradon
tradon
volital
volital

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT00000340	Phase 2	Jun 1, 1996	Friends Research Institute, Inc., National Institute on Drug Abuse (NIDA)
NCT00000282	Phase 2	Sep 1, 1994	Department of Veteran Affairs, National Institute on Drug Abuse (NIDA), Yale University

Showing 2 of 2 trials

Page 1 / 1

Organizations

Research & Development (4)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
National Institute on Drug Abuse (NIDA)	Government	2	1	1	1994
Department of Veteran Affairs	Government	1	0	1	1994
Friends Research Institute, Inc.	Academic/Hospital	1	0	1	1996
Yale University	Academic/Hospital	1	1	1	1994

4 organizations

Page 1 / 1

Marketing (8)

Organization	Org type	Relationship	Date
Abbott	For profit	NDA	Jan 27, 1975
Actavis	For profit	MKTG	Feb 28, 2000
Fosun	For profit	MKTG	Jun 30, 1999
International Minerals and Chemical Corporation	For profit	MKTG	Mar 30, 2001
Mallinckrodt	For profit	MKTG	Mar 30, 2001
Teva	For profit	MKTG	Jan 29, 1999
Vintage	For profit	MKTG	Apr 19, 2000
Watson Pharmaceuticals	For profit	MKTG	Sep 18, 2000