Phenergan

(Promethazine)

ApprovedSmall molecule

BBassett Healthcare

Phenergan is one of 44 small molecule programs targeting Nausea and vomiting. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Nausea and VomitingActive, not recruiting

Motion SicknessCompleted

Nausea and VomitingPreclinical

Active, not recruiting

Motion SicknessApproved

Completed

Competition

Competitive Landscape

78 competitors in Nausea and Vomiting

#DrugCompanyPhaseTrials

Duragesic

CCephalon

Approved

1 2

Xylocaine

MMEDRx USA, Inc.

Approved

1 3

Zithromax

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

1 4

Thalomid

Bristol-Myers Squibb

Phase 3

2 5

Phenergan

BBassett Healthcare

Approved

5 6

Megace

Bristol-Myers Squibb

Phase 3

1 7

Abraxane

Bristol-Myers Squibb

Phase 3

1 8

Gemzar

Johnson & Johnson

Phase 3

1 9

Nereus

VVanda Pharmaceuticals

Phase 3

2 10

HSK21542

Haisco Pharmaceutical Group Co., Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Nausea and vomiting5 trials

Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED

Terminated·VVanderbilt University·N/A·NCT00655642·171 enrolled

Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting

Terminated·WWomen's College Hospital·N/A·NCT01159548·400 enrolled

A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department

Completed·UUniversity of New Mexico·Phase 4·NCT00429832·120 enrolled

Show 2 more trials

Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

Completed·VVanderbilt University·N/A·NCT02625181·27,034 enrolled

Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting

Completed·SSergio Bergese·Phase 4·NCT01474915·122 enrolled

Vertigo1 trial

Promethazine vs. Lorazepam for Treatment of Vertigo

Completed·SShahid Beheshti University of Medical Sciences·Phase 3·NCT01827293·210 enrolled

Crohn's Disease1 trial

Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

Completed·UUniversity of Pennsylvania·Phase 2·NCT02765256·8 enrolled

Gastroparesis1 trial

Study of Promethazine for Treatment of Diabetic Gastroparesis

Terminated·—·Phase 2·NCT02130622·3 enrolled

Single Dose1 trial

Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects

Completed·IIndivior Inc.·Phase 4·NCT01846455·43 enrolled

6 more indications

Labor Pain1 trial

Effect of Hyoscine and Promethazine on Labor Pain

Completed·MMashhad University of Medical Sciences·Phase 2/3·NCT01644838·93 enrolled

Motion Sickness1 trial

Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels

Completed·FFaisal_Karmali@MEEI.HARVARD.EDU·Phase 4·NCT02136420·30 enrolled

Pruritus1 trial

Treatment of Pruritus With Intramuscular Promethazine

Completed·UUniversity of Florida·Phase 4·NCT04805073·72 enrolled

Nitrous Oxide1 trial

Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide for Uncooperative Children

Unknown status·SShahid Beheshti University·Phase 3·NCT01118884·20 enrolled

Endoscopic Retrograde Cholangiopancreatography (ERCP)1 trial

Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures

Completed·UUniversity of California, Irvine·Phase 4·NCT00937924·304 enrolled

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 19, 1973

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Jan 1, 1982

PHENERGAN

NDA NDA010926

Jan 1, 1982

PHENERGAN

NDA NDA008857

Jan 1, 1982

PHENERGAN

NDA NDA007935

Jan 1, 1982

PHENERGAN

NDA NDA011689

Apr 18, 1984

PROMETHAZINE HYDROCHLORIDE PLAIN

NDA NDA008381

Mar 30, 1990

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Aug 23, 1990

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Nov 9, 1990

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Mar 12, 1992

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Oct 30, 1992

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Jun 16, 1993

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Dec 27, 1994

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Feb 11, 1999

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Nov 19, 1999

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Aug 9, 2001

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Mar 12, 2002

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Nov 27, 2002

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Nov 27, 2002

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Apr 19, 2004

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Apr 19, 2004

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Jun 21, 2005

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Mar 13, 2006

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Nov 19, 2009

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Dec 27, 2023

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Jun 24, 2025

PROMETHAZINE HYDROCHLORIDE

NDA ANDA083312

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Promethazine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Promethazine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Promethazine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA ANDA083312). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bassett Healthcare company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: BBassett Healthcare

Phenergan

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Nausea and vomiting5 trials

Vertigo1 trial

Crohn's Disease1 trial

Gastroparesis1 trial

Single Dose1 trial

Labor Pain1 trial

Motion Sickness1 trial

Pruritus1 trial

Nitrous Oxide1 trial

Endoscopic Retrograde Cholangiopancreatography (ERCP)1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News