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HZT-501 · 3 trials · 6 indications
The primary efficacy endpoint was the number of subjects with upper gastrointestinal (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.
| Arm | Type | Description |
|---|---|---|
| HZT-501 | EXPERIMENTAL | Open-label treatment with HZT-501 |
| Ibuprofen | ACTIVE_COMPARATOR | Ibuprofen 800mg |
| 1 | EXPERIMENTAL | HZT-501: Ibuprofen 800mg/Famotidine 26.6mg |
| 2 | ACTIVE_COMPARATOR | Ibuprofen 800mg |
| Name | Type | Description |
|---|---|---|
| HZT-501 | DRUG | Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day |
| Ibuprofen | DRUG | Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks |
Inclusion Criteria: * Patient is capable of understanding the purpose and risks of the study and is able to provide written Informed Consent. * Patient is male or female, aged 40 to 80 years of age. * Patient is expected to require daily administration of an NSAID for at least the coming year for c...
HZT-501 is an investigational small molecule being developed for osteoarthritis and peptic ulcer. It is studied in patients who require long-term daily non-steroidal anti-inflammatory drug treatment, with the aim of reducing the risk of ibuprofen-associated ulcers.
HZT-501 is a combination of ibuprofen and famotidine. Ibuprofen is a nonsteroidal anti-inflammatory drug that reduces pain and inflammation, while famotidine is a histamine H2-receptor antagonist that reduces stomach acid production to help prevent ulcers.
HZT-501 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN.
HZT-501 is in Phase 3 clinical development. It is investigational and not yet approved by regulatory authorities. Three Phase 3 trials have been completed, with a total enrollment of 627 participants in the primary study.
HZT-501 has completed three Phase 3 trials: NCT00450658, which studied its efficacy in reducing ibuprofen-associated ulcers in 627 patients with peptic ulcer; NCT00613106, a follow-on safety study in 179 patients; and NCT00984815, a safety study in 86 patients requiring long-term NSAID treatment.
HZT-501 is a fixed-dose combination of ibuprofen 800 mg and famotidine 26.6 mg. It is designed to provide the analgesic and anti-inflammatory effects of ibuprofen while the famotidine component helps protect against gastrointestinal ulcers.