Pepcid

(Famotidine)

ApprovedSmall molecule

Famotidine is used to reduce stomach acid and treat heartburn, acid reflux, and ulcers by decreasing the amount of acid your stomach produces.[2] Pepcid is currently approved and in use across 26 indications[4].[1]

Pepcid is one of 521 small molecule programs targeting Post Operative Nausea and Vomiting. It is currently in Approved.

Indications

Total Trials

Active Trials

520

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Post Operative Nausea and VomitingActive, not recruiting

Rheumatoid ArthritisActive, not recruiting

Duodenal UlcerActive, not recruiting

Gastric UlcerActive, not recruiting

Chest PainActive, not recruiting

OsteoarthritisActive, not recruiting

Peptic UlcerActive, not recruiting

Ulcer DiseaseActive, not recruiting

FibrosisApproved

HIV InfectionActive, not recruiting

Post Operative Nausea and VomitingPreclinical

Active, not recruiting

Rheumatoid ArthritisApproved

Active, not recruiting

Duodenal UlcerApproved

Active, not recruiting

Gastric UlcerApproved

Active, not recruiting

Chest PainApproved

Active, not recruiting

OsteoarthritisApproved

Active, not recruiting

Peptic UlcerApproved

Active, not recruiting

Ulcer DiseaseApproved

Active, not recruiting

FibrosisApproved

Approved

HIV InfectionApproved

Active, not recruiting

Showing 10 of 26 indications

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Pepcid

KKenvue Brands

Approved

11 2

Stivarga

Bayer

Preclinical

1 3

Aimovig

Amgen

Preclinical

1 4

Aldactone

Pfizer

Preclinical

1 5

Nexavar

Bayer

Preclinical

1 6

Calciferol

Activella

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 9

Benadryl

PParkedale

Preclinical

1 10

Nitrostat

VViatris Specialty LLC

Preclinical

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

Timeline

Expected Milestones

Q2 2027

ApprovedRecruiting

Esophageal Motility Disorders

NCT05455359

Phase 1Recruiting

Study completion

NCT07629999

Q4 2027

PreclinicalRecruiting

Anemia, Sickle Cell

NCT06481306

ApprovedRecruiting

Multiple Myeloma

NCT07101445

Q1 2028

PreclinicalRecruiting

Adenocarcinoma

NCT06207305

Q2 2028

Phase 2Recruiting

Infantile Spasms

NCT06819670

Clinical

Trials by Indication[1]

COVID-1911 trials

Famotidine in Covid-19 Intensive Care Unit

Completed·IIstanbul Medeniyet University··NCT05122208·60 enrolled

Role of Famotidine in the Clinical Improvement of COVID-19 Patients.

Completed·—·Phase 3·NCT04504240·208 enrolled

Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients

Terminated·LLeidos Life Sciences·Phase 2·NCT05077969·4 enrolled

Show 8 more trials

Combined Antihistaminics Therapy in COVID 19 Patients

Completed·—·Phase 2/3·NCT05043350·214 enrolled

Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1)

Withdrawn·LLeidos Life Sciences·Phase 2·NCT05085574

Famotidine Outpatient COVID-19 Treatment Study

Completed·NNorthwell Health··NCT04389567·10 enrolled

An Outpatient Study Investigating Non-prescription Treatments for COVID-19

Terminated·PProfact, Inc.·Phase 2·NCT04621149·10 enrolled

Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19

Active, not recruiting·NNorthwell Health·Phase 2·NCT04724720·56 enrolled

Trial of Famotidine & N-Acetyl Cysteine for Outpatients With COVID-19

Terminated·PPrisma Health-Upstate·Phase 1·NCT04545008·2 enrolled

I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients

Active, not recruiting·QQuantumLeap Healthcare Collaborative·Phase 2·NCT04488081·1,500 enrolled

LEAP-CT for Treatment of COVID-19 Patients (Master Protocol)

Completed·LLeidos Life Sciences·Phase 2·NCT05077332·4 enrolled

Drug7 trials

A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05866627·76 enrolled

A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04941755·22 enrolled

A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06170723·32 enrolled

Show 4 more trials

A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04550195·26 enrolled

Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04470778·35 enrolled

A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04536961·56 enrolled

A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04175925·171 enrolled

Tics6 trials

A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants

Completed·PPMV Pharmaceuticals, Inc·Phase 1·NCT06054464·28 enrolled

A Study in Healthy Male Subjects to Understand How Savolitinib Behaves Inside the Body (Pharmacokinetics) When Administered Alone and in Combination With Famotidine

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04179071·16 enrolled

Anesthetics in Rhytidoplasty - A Comparison Study

Completed·MMercy Facial Plastic Surgery Center·N/A·NCT02410460·30 enrolled

Show 3 more trials

Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects

Completed·CCalithera Biosciences, Inc·Phase 1·NCT04540965·22 enrolled

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03142165·33 enrolled

A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

Completed· Amgen logo

Amgen·Phase 1·NCT05599828·14 enrolled

Oral5 trials

A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants

Completed· Incyte logo

Incyte·Phase 1·NCT07018635·63 enrolled

PK, PD and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects

Enrolling by invitation·HHK inno.N Corporation·Phase 1·NCT06332638·36 enrolled

A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04949269·61 enrolled

Show 2 more trials

A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations.

Completed· Pfizer logo

Pfizer·Phase 1·NCT04903093·19 enrolled

Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fed Conditions

Completed·PPerrigo Company·Phase 1·NCT00803192·44 enrolled

Age3 trials

Pharmacokinetic and Safety Study of Cenicriviroc and Acid Reducing Agents When Dosed Alone or in Combination

Completed·TTobira Therapeutics, Inc.·Phase 1·NCT02684799·48 enrolled

A Study to Explore the Effect of Acid-reducing Agents

Completed·MMirati Therapeutics Inc.·Phase 1·NCT04935112·15 enrolled

Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food

Completed· Pfizer logo

Pfizer·Phase 1·NCT02097329·27 enrolled

49 more indications

Prevention2 trials

Ulcer Prevention Study in Post Gastric Bypass Patients

Completed·UUniversity of Missouri-Columbia·Phase 4·NCT00557349·40 enrolled

ASP (PPI_H2RA) Study-H2RA Versus PPI for the Prevention of Recurrent UGIB in High-risk Users of Low-dose ASA

Completed·—·Phase 3·NCT01408186·264 enrolled

Adult2 trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participant

Completed· Incyte logo

Incyte·Phase 1·NCT06213818·137 enrolled

A Study to Evaluate the Bioequivalence Between Immediate Release Tablets and Minitablets of Deucravacitinib (BMS-986165), and the Effect of Food and pH on the Drug Levels of the Minitablets in Healthy Adults

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06851871·26 enrolled

Absorption2 trials

A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects

Completed·LLexicon Pharmaceuticals·Phase 1·NCT03302845·32 enrolled

A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06144697·267 enrolled

Fasting Conditions2 trials

Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fasting Conditions

Completed·PPerrigo Company·Phase 1·NCT00802828·44 enrolled

Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions

Completed·—·Phase 1·NCT01511731·30 enrolled

Dyspepsia2 trials

Famotidine and Antacids for Treatment of Dyspepsia

Recruiting·SStony Brook University·Phase 4·NCT06241183·80 enrolled

Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia

Unknown status·RRuttonjee Hospital·Phase 4·NCT00978159·128 enrolled

Esophagitis2 trials

Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine -

Completed· Taiho Pharmaceutical Co., Ltd. logo

Taiho Pharmaceutical Co., Ltd.·Phase 3·NCT00229424·325 enrolled

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients

Completed· Boryung Pharmaceutical Co., Ltd logo

Boryung Pharmaceutical Co., Ltd·Phase 3·NCT01499368·495 enrolled

Schizophrenia2 trials

Famotidine in Schizophrenia

Unknown status·JJesper Ekelund·Phase 2/3·NCT01946295·140 enrolled

Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

Completed·JJesper Ekelund·Phase 4·NCT00565175·30 enrolled

Gastric Adenocarcinoma2 trials

A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05977998·30 enrolled

Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT03330028·29 enrolled

Psoriasis2 trials

Safety Study of BMS-986165 in Healthy Subjects and to Treat Psoriasis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02534636·140 enrolled

Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02763969·357 enrolled

Congenital Heart Disease1 trial

Stress Ulcer Prophylaxis Versus Placebo in Critically Ill Infants With Congenital Heart Disease

Completed·—·Phase 4·NCT03667703·70 enrolled

Breast Cancer1 trial

Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel

Completed·OOhio State University Comprehensive Cancer Center·Phase 2/3·NCT04862585·130 enrolled

Head and Neck Cancer1 trial

Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer

Completed·UUniversity of Chicago·Phase 2·NCT03107182·72 enrolled

Efficacy and Safety1 trial

Placebo Controlled Phase IV Study to Compare the Efficacy and Safety of a Single Dose of Oral Talcid, a Single Dose of Oral Famotidine and a Single Dose of Placebo in Patients With Acute Heartburn Episodes

Completed· Bayer logo

Bayer·Phase 4·NCT01928888·559 enrolled

Sickle Cell Disease1 trial

Interest of Famotidine in Children With Sickle Cell Disease

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT05084521·30 enrolled

Clopidogrel1 trial

Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine

Completed·TTel-Aviv Sourasky Medical Center·Phase 4·NCT00950339·63 enrolled

Pulmonary Hypertension1 trial

Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension

Completed·UUniversity of Washington·Phase 2·NCT03554291·80 enrolled

Intensive Care Unit1 trial

Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit

Completed·FFar Eastern Memorial Hospital·Phase 4·NCT00633035·60 enrolled

Antiplatelet1 trial

Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin

Completed·RRuttonjee Hospital·Phase 4·NCT01062516·100 enrolled

HIV infection1 trial

Effects of Famotidine on the Pharmacokinetics of Atazanavir When Coadministered to Participants With HIV Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01232127·25 enrolled

Treatment1 trial

A Study Comparing the Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of BMS-986165 in Healthy Volunteers

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04209699·18 enrolled

Pain Management1 trial

Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery

Withdrawn·UUniversity of Miami·Phase 3·NCT05965492

Gastroesophageal Reflux Disease1 trial

Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease

Completed· Astellas logo

Astellas·Phase 2/3·NCT00141960·480 enrolled

Immunodeficiency1 trial

A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01000818·18 enrolled

Solid Tumors1 trial

Study of XL281 in Adults With Solid Tumors

Completed·EExelixis·Phase 1·NCT00451880·180 enrolled

Immunoglobulin G4-related Disease1 trial

Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04918147·8 enrolled

Drug Interactions1 trial

Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT03451110·50 enrolled

Helicobacter Pylori1 trial

PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers

Completed·—·Phase 4·NCT01180179·228 enrolled

ART1 trial

A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04453189·14 enrolled

Pneumonia1 trial

Proton Pump Inhibitors and Risk of Community-acquired Pneumonia

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02555852·4,238,504 enrolled

Intraperitoneal Chemotherapy1 trial

A Phase II Trial of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Chemoradiation

Unknown status·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT04308837·29 enrolled

Fed1 trial

A Relative Bioavailability Study of 20 mg Famotidine Tablets Under Fed Condition

Completed·RRanbaxy Laboratories Limited·N/A·NCT01079052·24 enrolled

Coronavirus1 trial

Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial

Terminated·EEmory University·Phase 3·NCT05946551·5 enrolled

Levodopa1 trial

Famotidine for Levodopa-induced Dyskinesia in PD

Completed·UUniversity Health Network, Toronto·Phase 2·NCT01937078·7 enrolled

General Anesthesia1 trial

Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia

Enrolling by invitation·SSeok Kyeong Oh·Phase 4·NCT06743243·174 enrolled

Laryngomalacia1 trial

Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia

Terminated·RReema Padia·Phase 1/2·NCT04614974·65 enrolled

Eosinophilic Esophagitis1 trial

Antihistamines in Eosinophilic Esophagitis

Terminated·MMayo Clinic·Phase 2·NCT04248712·1 enrolled

Gene Therapy1 trial

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT05035407·36 enrolled

Infantile Spasms1 trial

A Study to Prevent Infantile Spasms Relapse

Recruiting·UUniversity of California, Los Angeles·Phase 2·NCT06819670·40 enrolled

AIN1 trial

Histamine H1/H2 Receptors and Training Adaptations

Completed·UUniversity Ghent·N/A·NCT04450134·19 enrolled

Stroke1 trial

Histamine Glutamate Antagonism in Stroke

Completed·UUniversity of Florida·Phase 2·NCT02142712·3 enrolled

Heart Disease1 trial

Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

Completed·RRuttonjee Hospital·Phase 4·NCT00683111·500 enrolled

Acute Kidney Injury1 trial

Prevention of Post-Cardiac Surgery Acute Kidney Injury by Proton Pump Inhibitor

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT06154226·100 enrolled

Malignant Mesothelioma1 trial

Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT04840615·2 enrolled

Anemia, Sickle Cell1 trial

A Phase 1/2a, First-in-human, Randomized, Double-blinded, Placebo-controlled, Dose-finding Study in Healthy Volunteers and Participants With Sickle Cell Disease to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, pH and Food Effect, and Preliminary Efficacy of BMS-986470

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Preclinical·NCT06481306·224 enrolled

Esophageal Motility Disorders1 trial

The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms

Recruiting·BBoston Children's Hospital·Approved·NCT05455359·120 enrolled

Multiple Myeloma1 trial

Prevent Allergic Reactions to Aphexda With Dexamethasone (PARADE)

Recruiting·EEmory University·Approved·NCT07101445·94 enrolled

Adenocarcinoma1 trial

A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06207305·39 enrolled

Hairy Cell Leukemia1 trial

A Phase I Study of Moxetumomab Pasudotox-tdfk (Lumoxiti (TM)) and Either Rituximab (Rituxan (R)) or Ruxience for Relapsed Hairy Cell Leukemia

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT03805932·18 enrolled

Unspecified5 trials

A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04065932·33 enrolled

A Relative Bioavailability Study of 20 mg Famotidine Tablets Under Fasting Condition

Completed·RRanbaxy Laboratories Limited·N/A·NCT01079065·32 enrolled

A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant.

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT04390334·24 enrolled

Show 2 more trials

A Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Tolerability of NX-5948 Tablets Following Single and Multiple Ascending Doses, the Relative Bioavailability of NX-5948 Tablets Compared to Capsules, the Effect of NX-5948 on the QT Interval, the Effect of Food on the Pharmacokinetics of NX-5948, Drug-Drug Interactions With NX-5948, and the Intra-Subject Variability of the Bioavailability of NX-5948 Capsules

Completed·NNurix Therapeutics, Inc.·Phase 1·NCT06717269·223 enrolled

A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986533 in Healthy Participants, an Open-label Assessment of Food and pH Effects on the Relative Bioavailability of BMS-986533, and an Open-label Study to Evaluate P-gp- and BCRP-mediated Drug-Drug Interaction Potential of BMS-986533 in Healthy Participants

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT07629999·136 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 15, 1986

PEPCID

NDA NDA019462

Nov 4, 1986

PEPCID

NDA NDA019510

Feb 2, 1987

PEPCID

NDA NDA019527

Feb 18, 1994

PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

NDA NDA020249

Apr 28, 1995

PEPCID AC

NDA NDA020325

Apr 28, 1995

PEPCID AC

NDA NDA020325

Oct 2, 1995

PEPCID AC

NDA NDA020325

Apr 23, 1996

PEPCID AC

NDA NDA020325

May 3, 1996

PEPCID AC

NDA NDA020325

Sep 26, 1997

PEPCID AC

NDA NDA020325

Apr 15, 1998

PEPCID AC

NDA NDA020325

May 28, 1998

PEPCID RPD

NDA NDA020752

Sep 24, 1998

PEPCID AC

NDA NDA020801

Nov 5, 1998

PEPCID AC

NDA NDA020325

Nov 9, 1998

PEPCID AC

NDA NDA020325

Aug 5, 1999

PEPCID AC

NDA NDA020902

Feb 10, 2000

PEPCID AC

NDA NDA020325

Apr 5, 2000

PEPCID AC

NDA NDA020325

Oct 16, 2000

PEPCID COMPLETE

NDA NDA020958

Apr 16, 2001

FAMOTIDINE

NDA ANDA075805

Nov 6, 2001

PEPCID COMPLETE

NDA NDA020958

Mar 1, 2002

PEPCID AC

NDA NDA020325

Nov 22, 2002

PEPCID COMPLETE

NDA NDA020958

Sep 23, 2003

PEPCID AC

NDA NDA020325

Nov 5, 2003

PEPCID COMPLETE

NDA NDA020958

Sep 24, 2004

FLUXID

NDA NDA021712

Oct 27, 2004

PEPCID COMPLETE

NDA NDA020958

Oct 27, 2004

PEPCID AC

NDA NDA020325

Jul 18, 2005

PEPCID COMPLETE

NDA NDA020958

Jun 9, 2006

PEPCID AC

NDA NDA020325

Jun 9, 2006

PEPCID COMPLETE

NDA NDA020958

Nov 18, 2008

PEPCID COMPLETE

NDA NDA020958

Jun 13, 2012

FAMOTIDINE

NDA ANDA075805

Oct 11, 2012

PEPCID AC

NDA NDA020325

Apr 1, 2013

PEPCID AC

NDA NDA020325

Apr 1, 2013

PEPCID COMPLETE

NDA NDA020958

Jul 30, 2013

PEPCID COMPLETE

NDA NDA020958

Dec 7, 2013

PEPCID COMPLETE

NDA NDA020958

Mar 20, 2014

PEPCID COMPLETE

NDA NDA020958

Apr 20, 2015

PEPCID AC

NDA NDA020325

May 6, 2015

PEPCID AC

NDA NDA020325

Jul 9, 2015

PEPCID AC

NDA NDA020325

Jul 14, 2015

PEPCID COMPLETE

NDA NDA020958

May 5, 2016

PEPCID AC

NDA NDA020325

Jun 8, 2016

PEPCID COMPLETE

NDA NDA020958

Jun 8, 2016

PEPCID AC

NDA NDA020325

Aug 1, 2016

PEPCID AC

NDA NDA020325

Dec 21, 2018

PEPCID COMPLETE

NDA NDA020958

Apr 9, 2019

PEPCID COMPLETE

NDA NDA020958

Apr 9, 2019

PEPCID AC

NDA NDA020325

Jun 11, 2019

PEPCID COMPLETE

NDA NDA020958

May 13, 2020

FAMOTIDINE

NDA ANDA075805

Feb 18, 2022

PEPCID AC

NDA NDA020325

Dec 15, 2022

PEPCID AC

NDA NDA020325

Dec 14, 2023

PEPCID AC

NDA NDA020325

Jan 17, 2025

PEPCID COMPLETE

NDA NDA020958

Jan 31, 2025

PEPCID COMPLETE

NDA NDA020958

Feb 11, 2025

PEPCID COMPLETE

NDA NDA020958

Jul 16, 2025

FAMOTIDINE

NDA NDA219935

Sep 30, 2025

PEPCID COMPLETE

NDA NDA020958

Feb 12, 2026

PEPCID AC

NDA NDA020325

Sources

References

[1]
ClinicalTrials.gov — 94 trial records for Famotidine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Pepcid drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Famotidine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Famotidine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020325). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Kenvue Brands company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Histamine H2 Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: KKenvue Brands

Pepcid

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q1 2028

Q2 2028

Trials by Indication[1]

COVID-1911 trials

Drug7 trials

Tics6 trials

Oral5 trials

Age3 trials

Prevention2 trials

Adult2 trials

Absorption2 trials

Fasting Conditions2 trials

Dyspepsia2 trials

Esophagitis2 trials

Schizophrenia2 trials

Gastric Adenocarcinoma2 trials

Psoriasis2 trials

Congenital Heart Disease1 trial

Breast Cancer1 trial

Head and Neck Cancer1 trial

Efficacy and Safety1 trial

Sickle Cell Disease1 trial

Clopidogrel1 trial

Pulmonary Hypertension1 trial

Intensive Care Unit1 trial

Antiplatelet1 trial

HIV infection1 trial

Treatment1 trial

Pain Management1 trial

Gastroesophageal Reflux Disease1 trial

Immunodeficiency1 trial

Solid Tumors1 trial

Immunoglobulin G4-related Disease1 trial

Drug Interactions1 trial

Helicobacter Pylori1 trial

ART1 trial

Pneumonia1 trial

Intraperitoneal Chemotherapy1 trial

Fed1 trial

Coronavirus1 trial

Levodopa1 trial

General Anesthesia1 trial

Laryngomalacia1 trial

Eosinophilic Esophagitis1 trial

Gene Therapy1 trial

Infantile Spasms1 trial

AIN1 trial

Stroke1 trial

Heart Disease1 trial

Acute Kidney Injury1 trial

Malignant Mesothelioma1 trial

Anemia, Sickle Cell1 trial

Esophageal Motility Disorders1 trial

Multiple Myeloma1 trial

Adenocarcinoma1 trial

Hairy Cell Leukemia1 trial

Unspecified5 trials

FDA Approval Timeline[5]

References

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