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Ibuprofen/famotidine
This combination drug reduces stomach acid (via famotidine, an H2-receptor antagonist) while providing anti-inflammatory and analgesic effects (via ibuprofen, an NSAID), designed to minimize gastrointestinal injury from NSAID use.
This combination drug reduces stomach acid (via famotidine, an H2-receptor antagonist) while providing anti-inflammatory and analgesic effects (via ibuprofen, an NSAID), designed to minimize gastrointestinal injury from NSAID use. Used for Chronic pain conditions where NSAID use is indicated, with reduced gastrointestinal risk.
At a glance
| Generic name | Ibuprofen/famotidine |
|---|---|
| Sponsor | Amgen |
| Drug class | NSAID with gastroprotective agent |
| Target | COX-1/COX-2 (ibuprofen); H2 histamine receptor (famotidine) |
| Modality | Small molecule |
| Therapeutic area | Pain management / Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Ibuprofen is a nonsteroidal anti-inflammatory drug that inhibits cyclooxygenase (COX) enzymes to reduce inflammation and pain. Famotidine is an H2-receptor antagonist that decreases gastric acid secretion. The combination aims to provide NSAID efficacy while reducing the risk of NSAID-induced gastrointestinal ulcers and bleeding, a known adverse effect of ibuprofen monotherapy.
Approved indications
- Chronic pain conditions where NSAID use is indicated, with reduced gastrointestinal risk
Common side effects
- Dyspepsia
- Nausea
- Headache
- Abdominal pain
Key clinical trials
- Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment (PHASE3)
- Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216) (PHASE3)
- Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers (PHASE3)
- Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis (PHASE4)
- Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment (PHASE3)
- Safety, Tolerability, and Pharmacokinetics of UX053 in Patients With Glycogen Storage Disease Type III (GSD III) (PHASE1, PHASE2)
- Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery (PHASE4)
- Influence of Medication Taste on Pediatric Prescribers' Prescribing Habits (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ibuprofen/famotidine CI brief — competitive landscape report
- Ibuprofen/famotidine updates RSS · CI watch RSS
- Amgen portfolio CI