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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...
Top 5 of 14 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, Eloralintide, LY3016859, LY3556050, LY3526318 |
| Pacira Biosciences, Inc. | PCRX | 4 | PHASE3 | ZILRETTA, Enekinragene Inzadenovec, FX201 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | NNC0487-0111 |
| Bioventus, Inc. Class A | BVS | 1 | PHASE2 | PTP-001 |
| Enlivex Ltd. | ENLV | 2 | PHASE1 | Allocetra |
HZT-501 is an investigational small molecule being developed for peptic ulcer and osteoarthritis. It is intended to reduce the risk of ibuprofen-associated ulcers in patients who require non-steroidal anti-inflammatory drug treatment. The drug is currently in Phase 3 clinical development and is not yet approved.
HZT-501 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in reducing the risk of ibuprofen-associated ulcers.
HZT-501 is in Phase 3 clinical development. Three Phase 3 trials have been completed, with a total enrollment of 627 patients across studies. The drug is investigational and has not been approved by regulatory authorities. All completed trials were randomized, double-blind, and active-controlled.
HZT-501 has completed three Phase 3 trials. NCT00450658 evaluated its efficacy in reducing ibuprofen-associated ulcers in 627 patients with peptic ulcer. NCT00613106 and NCT00984815 were follow-on safety studies in patients with osteoarthritis and other chronic pain conditions requiring long-term NSAID treatment.
HZT-501 combines ibuprofen, a nonsteroidal anti-inflammatory drug that reduces pain and inflammation, with famotidine, a histamine H2-receptor antagonist that decreases stomach acid production. This dual mechanism aims to maintain the analgesic benefits of ibuprofen while protecting against the development of peptic ulcers.