Drugs / Nefazodone

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) SERZONE 2009-03-13 fda.gov
Approved US (FDA) SERZONE 1994-12-22 fda.gov

Trials 4 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT00249509 Sep 2000 → Sep 2004 hallucinogen abuse National Institute on Drug Abuse (NIDA) Completed No outcome recorded
Phase 2 NCT00000286 Dec 1996 → Dec 2001 substance-related disorder National Institute on Drug Abuse (NIDA) Completed No outcome recorded
Phase 31 trial
Phase 3 NCT00000293 Jan 1999 → Dec 2001 substance-related disorder National Institute on Drug Abuse (NIDA) Completed No outcome recorded
Phase 41 trial
Phase 4 NCT00231348 ? → Apr 2000 social phobia Emory University Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT00015210 Comparator Feb 1997 → May 1999 cocaine dependence Boston Medical Center Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2003-09-16 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Approval of Nefazodone HCl Tablets 50 mg, 100 mg, 150 mg, 200 mg and 250 mg tevapharm.com

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as Nefazodone ClinicalTrials.gov intervention name — accepted as the source's own label NCT00000286
4

NCT00231348

NCT00015210

NCT00000293

NCT00249509

Known as BMY 13754 ChEMBL registry synonym — accepted as the source's own label CHEMBL623
Known as Dutonin ChEMBL registry synonym — accepted as the source's own label CHEMBL623
Known as MJ 13,754-1 ChEMBL registry synonym — accepted as the source's own label CHEMBL623
Known as Nefazodona ChEMBL registry synonym — accepted as the source's own label CHEMBL623
Known as Nefazodone hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL623
Known as NEFAZODONE HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL623
Known as NSC-760344 ChEMBL registry synonym — accepted as the source's own label CHEMBL623
Known as Serzone ChEMBL registry synonym — accepted as the source's own label CHEMBL623
Action Inhibit “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL623
4

“Serotonin 2c (5-HT2c) receptor antagonist” CHEMBL623

“Norepinephrine transporter inhibitor” CHEMBL623

“5HT2 receptor antagonist nefazadone” NCT00231348

“Serotonin transporter inhibitor” CHEMBL623

Modality Small molecule CHEMBL623
Target HTR2A “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL623
Target HTR2C “Serotonin 2c (5-HT2c) receptor antagonist” CHEMBL623
Target SLC6A2 “Norepinephrine transporter inhibitor” CHEMBL623
Target SLC6A4 “Serotonin transporter inhibitor” CHEMBL623