Zantac 150

(Ranitidine)

ApprovedSmall molecule

Zantac 150 is a small molecule that works as a Histamine H2 Receptor Antagonist; Histamine H2 Receptor Antagonist; Histamine H2 Receptor Antagonist.[2] It is being used across 12 indications, with its most advanced program in Approved.[1]

Zantac 150 is one of 288 small molecule programs targeting Dyspepsia. It is currently in Approved.

Indications

Total Trials

Active Trials

287

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

DyspepsiaActive, not recruiting

StrokeActive, not recruiting

Barrett's EsophagusApproved

Immune System DiseaseApproved

PneumoniaActive, not recruiting

Peptic UlcerActive, not recruiting

Laryngopharyngeal RefluxWithdrawn

Medullary Thyroid Gland CarcinomaApproved

Prostate CancerCompleted

Renal Cell CarcinomaApproved

DyspepsiaPreclinical

Active, not recruiting

StrokePreclinical

Active, not recruiting

Barrett's EsophagusApproved

Approved

Immune System DiseaseApproved

Approved

PneumoniaPreclinical

Active, not recruiting

Peptic UlcerApproved

Active, not recruiting

Laryngopharyngeal RefluxApproved

Withdrawn

Medullary Thyroid Gland CarcinomaApproved

Approved

Prostate CancerApproved

Completed

Renal Cell CarcinomaApproved

Approved

Showing 10 of 11 indications

Competition

Competitive Landscape

312 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Lupron

EEastern Cooperative Oncology Group

Phase 3

53 2

Zantac 150

CChattem

Approved

1 3

Glucophage

EMD Serono

Phase 3

14 4

Antiandrogen Therapy

UUniversity of Washington

Phase 3

9 5

Radium-223

Bayer

Phase 3

6 6

Androgen Deprivation Treatment

MMedical University of Vienna

Phase 3

1 7

Fuzuloparib

JJiangsu HengRui Medicine Co., Ltd.

Phase 3

1 8

Trexall

Jazz Pharmaceuticals

Preclinical

—9

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 10

Botox

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

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

Clinical

Trials by Indication[1]

Tics3 trials

Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01682408·28 enrolled

Study in Healthy Volunteers to Assess Effect of Omeprazole and Ranitidine on the Pharmacokinetics of Vandetanib

Completed· Sanofi logo

Sanofi·Phase 1·NCT01539655·34 enrolled

A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01392755·32 enrolled

Gastroesophageal Reflux Disease3 trials

Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants

Completed·TThe University of Texas Health Science Center, Houston·Phase 3·NCT00131248·18 enrolled

Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)

Completed· Eisai logo

Eisai·Phase 3·NCT00839306·240 enrolled

Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)

Completed· Eisai logo

Eisai·Phase 3·NCT00838526·240 enrolled

Gastric Ulcer3 trials

A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00633672·400 enrolled

Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00401752·397 enrolled

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00633412·400 enrolled

Intravenous2 trials

A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain

Completed·PPamukkale University·Phase 4·NCT02197143·286 enrolled

Comparison of Intravenous Omeprazole to Ranitidine on Recurrent Bleeding After Endoscopic Treatment of Bleeding Ulcer

Withdrawn·KKeio University·Phase 4·NCT00247130

Dyspepsia2 trials

Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)

Completed·RRadboud University Medical Center·N/A·NCT00247715·664 enrolled

Comparison of Pantoprazole and Ranitidine in Dyspepsia

Completed·—·Phase 4·NCT01737840·66 enrolled

23 more indications

Interaction2 trials

A Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Participants

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03468777·18 enrolled

Lesinurad Interaction Study With Ranitidine

Completed·AArdea Biosciences, Inc.·Phase 1·NCT01908257·16 enrolled

Pneumonia2 trials

A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia

Completed·MMaulana Azad Medical College·Phase 4·NCT00702871·50 enrolled

Proton Pump Inhibitors and Risk of Community-acquired Pneumonia

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

Breast Cancer2 trials

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

TPI 287 in Breast Cancer Metastatic to the Brain

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01332630·24 enrolled

Clopidogrel2 trials

Does Pantoprazole Reduce the Anti-platelet Effect of Clopidogrel?

Completed·SSeoul National University Bundang Hospital·N/A·NCT02733640·42 enrolled

Ranitidin Versus Omeprazole in Patients Taking Clopidogrel

Completed·UUniversity of Sao Paulo General Hospital·Phase 4·NCT01896557·92 enrolled

Fasting Conditions1 trial

Bioequivalency Study of Ranitidine Tablets 300 mg of Dr. Reddy's Under Fasting Conditions

Completed·—·Phase 1·NCT01131702·24 enrolled

Prostate Cancer1 trial

Combination of Cabazitaxel With Prednisolone With Primary Prophylaxis With PEG-G-CSF in Treatment of Patients With Prostate Cancer

Completed· Sanofi logo

Sanofi·Phase 4·NCT02441894·21 enrolled

Critically Ill Patients1 trial

Gastric pH in Critically Ill Patients

Completed·MMedical University of Vienna·Phase 4·NCT00590928·75 enrolled

Prevention1 trial

Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering

Unknown status·LLagos State Health Service Commission·Phase 2·NCT02441673·130 enrolled

Reflux1 trial

Bronchial Hyper-responsiveness in Reflux Cough

Terminated·HHull University Teaching Hospitals NHS Trust·Phase 3·NCT00668317·5 enrolled

Stroke1 trial

Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting

Completed·UUniversity of Iowa·N/A·NCT00585351·100 enrolled

Excretion1 trial

Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT04397445·18 enrolled

Kidney Cancer1 trial

BMS 247550 to Treat Kidney Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00030992·102 enrolled

Leukemia1 trial

Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Terminated· Sanofi logo

Sanofi·Phase 2·NCT02999633·14 enrolled

Single Dose1 trial

Effect of Single Doses of YF476 on Stomach Acidity Compared With Ranitidine and Placebo in Fasted and Fed States

Completed·TTrio Medicines Ltd.·Phase 1·NCT01538797·22 enrolled

Laryngopharyngeal Reflux1 trial

The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux

Withdrawn·LLoma Linda University·Phase 4·NCT02123498

Immunity1 trial

Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity

Completed·NNova Scotia Health Authority·Phase 4·NCT03145012·30 enrolled

Cesarean Delivery1 trial

Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

Unknown status·—·Phase 2·NCT03140033·158 enrolled

ART1 trial

Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05338502·20 enrolled

Infusion1 trial

Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA

Completed· Sanofi logo

Sanofi·Phase 4·NCT02205489·58 enrolled

Infection1 trial

Effect of Ranitidine on Hyper-IgE Recurrent Infection (Job's) Syndrome

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00527878·16 enrolled

Multiple Sclerosis1 trial

A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)

Terminated· Sanofi logo

Sanofi·Phase 3·NCT03368664·16 enrolled

Schizophrenia1 trial

EMERGE-3: KarXT in Acute Schizophrenia

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT04681105·580 enrolled

Unspecified1 trial

Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02170792·30 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 9, 1983

ZANTAC 150

NDA NDA018703

Oct 19, 1984

ZANTAC

NDA NDA019090

Dec 30, 1988

ZANTAC

NDA NDA019675

Sep 27, 1991

ZANTAC IN PLASTIC CONTAINER

NDA NDA019593

Mar 8, 1994

ZANTAC 150

NDA NDA020095

Mar 31, 1994

ZANTAC 150

NDA NDA020251

Dec 19, 1995

ZANTAC 75

NDA NDA020520

Feb 26, 1998

ZANTAC 75

NDA NDA020745

Aug 31, 2004

ZANTAC 150

NDA NDA021698

Sources

References

[1]
ClinicalTrials.gov — 40 trial records for Ranitidine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ranitidine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ranitidine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021698). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Chattem company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Histamine H2 Receptor Antagonist; Histamine H2 Receptor Antagonist; Histamine H2 Receptor Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: CChattem

Zantac 150

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Tics3 trials

Gastroesophageal Reflux Disease3 trials

Gastric Ulcer3 trials

Intravenous2 trials

Dyspepsia2 trials

Interaction2 trials

Pneumonia2 trials

Breast Cancer2 trials

Clopidogrel2 trials

Fasting Conditions1 trial

Prostate Cancer1 trial

Critically Ill Patients1 trial

Prevention1 trial

Reflux1 trial

Stroke1 trial

Excretion1 trial

Kidney Cancer1 trial

Leukemia1 trial

Single Dose1 trial

Laryngopharyngeal Reflux1 trial

Immunity1 trial

Cesarean Delivery1 trial

ART1 trial

Infusion1 trial

Infection1 trial

Multiple Sclerosis1 trial

Schizophrenia1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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