Data updated: May 26, 2026
FAMOTIDINE PRESERVATIVE FREE (famotidine)
Histamine H2 Receptor Antagonists
Gastrointestinal
Approved 2001-04-16
FAMOTIDINE PRESERVATIVE FREE is indicated for the treatment of Duodenal Ulcer; Gastric Ulcer; Gastroesophageal Reflux Disease; Erosive Esophagitis; Pathological Hypersecretory Conditions; Zollinger-Ellison Syndrome; Multiple Endocrine Neoplasia.
Source: FDA Label • Viatris • Histamine-2 Receptor Antagonist
How FAMOTIDINE PRESERVATIVE FREE Works
Famotidine is a competitive inhibitor of histamine-2 (H2) receptors. Its primary clinical activity is the inhibition of gastric secretion, effectively reducing both the acid concentration and the total volume of gastric juice. Additionally, famotidine suppresses pepsin secretion in a manner proportional to the reduction in gastric volume output.
Source: FDA Label
5
Indications
--
Phase 3 Trials
25
Years on Market
Details
- Status
- Prescription
- First Approved
- 2001-04-16
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
FAMOTIDINE PRESERVATIVE FREE Approval History
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Original
New Indication
New Form
Label Update
19 FDA actions from 2001 to 2021
Sep 2021 SUPPL
Label · Labeling
Sep 2020 SUPPL
Label · Labeling
Sep 2020 SUPPL
Label · Labeling
Sep 2020 SUPPL
Label
Jun 2008 ORIGINAL
Update
Jun 2008 SUPPL
Label
May 2008 SUPPL
Label
Dec 2002 SUPPL
Mfg
Nov 2002 ORIGINAL
Update
Nov 2002 SUPPL
Mfg
Jun 2002 SUPPL
Mfg
Apr 2002 ORIGINAL
Update
What FAMOTIDINE PRESERVATIVE FREE Treats
7 indicationsFAMOTIDINE PRESERVATIVE FREE is approved for 7 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Duodenal Ulcer
- Gastric Ulcer
- Gastroesophageal Reflux Disease
- Erosive Esophagitis
- Pathological Hypersecretory Conditions
- Zollinger-Ellison Syndrome
- Multiple Endocrine Neoplasia
Source: FDA Label
FAMOTIDINE PRESERVATIVE FREE Competitive Set
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Clinical Trial Registry
63 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05866627 | IM026-1023 1007296 | Ph 1 | completed | A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants |
| NCT06481306 | CA230-1019 2023-510283-12, U1111-1301-6753 | Ph 1, Ph 2 | recruiting | A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease |
| NCT04488081 I-SPY_COVID | I-SPY-COVID | Ph 2 | active not recruiting | I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients |
| NCT06154226 results posted | HSC-MS-22-0502 | Ph 2 | completed | Prevention of Post-Cardiac Surgery Acute Kidney Injury by Proton Pump Inhibitor |
| NCT07101445 | STUDY00008909 NCI-2025-03018, STUDY00008909 | Ph 4 | recruiting | Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial |
| NCT04918147 results posted | DAIT AIG01 UM1AI144298, NIAID CRMS ID#: 38708 | Ph 2 | terminated | Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD) |
| NCT06207305 | 2023-0860 NCI-2024-00080 | Ph 1, Ph 2 | recruiting | A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma |
| NCT05455359 | IRB-P00038381 | Ph 4 | recruiting | Gastrointestinal Dysmotility on Aspiration Risk |
| NCT05077332 | LDOS-21-001 | Ph 2 | completed | LEAP-CT for Treatment of COVID-19 Patients (Master Protocol) |
| NCT05035407 results posted | 10000045 000045-C | Ph 1 | terminated | T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers |
| NCT07018635 | INCB161734-103 | Ph 1 | completed | A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants |
| NCT05977998 | 2023-0331 NCI-2023-05915 | Ph 2 | recruiting | A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology |
| NCT06213818 | INCB160058-102 | Ph 1 | completed | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participant |
| NCT06743243 | KCAB_032 | Ph 4 | enrolling by invitation | Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia |
| NCT04862585 results posted | OSU-20429 NCI-2021-01586 | Ph 2, Ph 3 | completed | Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel |
| NCT03805932 results posted | 190042 19-C-0042 | Ph 1 | active not recruiting | Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia |
| NCT04614974 results posted | STUDY20090193 | Ph 1, Ph 2 | terminated | Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia |
| NCT05946551 results posted | STUDY00005537 | Ph 3 | terminated | Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial |
| NCT05965492 | 20230423 | Ph 3 | withdrawn | Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery |
| NCT06819670 | 22-001710 20224426 | Ph 2 | recruiting | A Study to Prevent Infantile Spasms Relapse |
| NCT03107182 OPTIMA-II results posted | IRB17-0104 | Ph 2 | completed | Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer |
| NCT06851871 | IM011-1178 | Ph 1 | completed | 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 |
| NCT04470778 | IM026-028 | Ph 1 | completed | Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy Participants |
| NCT06144697 | CN009-1024 | Ph 1 | terminated | 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 |
| NCT04453189 | CR108812 2020-000380-23, 64417184RSV1004 | Ph 1 | completed | A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants |
| NCT01499368 results posted | LAF-BR-CT-302 | Ph 3 | completed | 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 |
| NCT05599828 | 20200199 | Ph 1 | completed | A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants |
| NCT04903093 results posted | B7451061 | Ph 1 | completed | 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. |
| NCT06054464 | PMV-586-104 | Ph 1 | completed | A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants |
| NCT05077969 results posted | LDOS-21-001-02 | Ph 2 | terminated | Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients |
| NCT06170723 | IM045-1002 | Ph 1 | completed | A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants |
| NCT04840615 results posted | 10000059 000059-C | Ph 1 | terminated | Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma |
| NCT05085574 | LDOS-21-001-01 | Ph 2 | withdrawn | Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1) |
| NCT05043350 | ACUCFPASURHDIRB2020110301REC43 | Ph 2, Ph 3 | completed | Combined Antihistaminics Therapy in COVID 19 Patients |
| NCT03330028 | 2017-0232 NCI-2018-01035 | Ph 1 | completed | Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology |
| NCT04248712 ATEE results posted | 19-005510 | Ph 2 | terminated | Antihistamines in Eosinophilic Esophagitis |
| NCT04621149 PROFACT-01 | Profact-01 | Ph 2 | terminated | An Outpatient Study Investigating Non-prescription Treatments for COVID-19 |
| NCT03667703 SUPPRESS-CHD | IRB-P00028715 | Ph 4 | completed | Stress Ulcer Prophylaxis Versus Placebo in Critically Ill Infants With Congenital Heart Disease |
| NCT04935112 | 516-011 | Ph 1 | completed | A Study to Explore the Effect of Acid-reducing Agents |
| NCT04175925 | IM032-007 | Ph 1 | completed | A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants |
| NCT04724720 | 20-1155 | Ph 2 | active not recruiting | Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19 |
| NCT04949269 | IM011-120 | Ph 1 | completed | A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants |
| NCT04550195 | IM037-009 2019-004518-32 | Ph 1 | completed | A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants |
| NCT04545008 results posted | Pro00100394 | Ph 1 | terminated | Trial of Famotidine & N-Acetyl Cysteine for Outpatients With COVID-19 |
| NCT04941755 | IM026-029 | Ph 1 | completed | A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants |
| NCT04536961 | IM011-136 | Ph 1 | completed | A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants |
| NCT04540965 | CX-839-015 | Ph 1 | completed | Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects |
| NCT04065932 | IM011-020 | Ph 1 | completed | A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets |
| NCT04390334 | ID-078-120 2020-000653-27 | Ph 1 | completed | 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. |
| NCT04179071 | D5084C00005 | Ph 1 | completed | A Study in Healthy Male Subjects to Understand How Savolitinib Behaves Inside the Body (Pharmacokinetics) When Administered Alone and in Combination With Famotidine |
Showing 50 of 63 trials
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FAMOTIDINE PRESERVATIVE FREE FDA Label Details
Indications & Usage
FAMOTIDINE PRESERVATIVE FREE is indicated for the treatment of Duodenal Ulcer; Gastric Ulcer; Gastroesophageal Reflux Disease; Erosive Esophagitis; Pathological Hypersecretory Conditions; Zollinger-Ellison Syndrome; Multiple Endocrine Neoplasia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.