Clinical Trials

Learn more about HZT-501

Clinical Trials

Horizon Therapeutics has closed enrollment
in both Phase 3 clinical studies

Horizon has successfully completed early supportive clinical studies on its lead investigational product candidate HZT-501 to:

  1. Validate the PK/PD formulation design
  2. Verify and define the effects and safety of several formulations on gastric pH
  3. Confirm that no significant drug-drug interactions exist between ibuprofen and famotidine
  4. Establish the comparative bioavailability of HZT-501 to approved reference drug products

Phase 3 Trials: REDUCE-1 and REDUCE-2

The Registration Endoscopic Study to Determine Ulcer Formation of HZT 501 Compared to Ibuprofen: Efficacy and Safety Study (REDUCE 1 and REDUCE 2) were two randomized, double-blind, controlled trials that evaluated the efficacy and safety of HZT-501 in reducing the risk of development of ibuprofen-associated upper gastrointestinal ulcers in patients who require use of ibuprofen. Both studies were identical in design and were conducted in the United States. Over 1500 patients participated. The trials were conducted via a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA).

HZT 501, a novel, proprietary fixed-dose combination product containing ibuprofen and famotidine, demonstrated a statistically significant reduction in the incidence of non-steroidal anti-inflammatory drug (NSAID)-induced upper gastrointestinal (gastric and/or duodenal) ulcers in patients with mild-to-moderate pain when compared to ibuprofen alone.

Contact Information

For further information on the REDUCE studies, please contact the Horizon Clinical Information line at 1-866-565-0259.

In the event of a medical emergency on either the REDUCE-1 or REDUCE-2 studies, please call 1-866-326-5053.

Disclosure of Risks

Please note that the safety and effectiveness of this product have not yet been established. As with ibuprofen and famotidine, this investigational product may not benefit you and may cause side effects that are not known or predictable at this time, but that may occur at the time of treatment or later. You should discuss these risks with your physician or a study doctor. All NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. The presence of famotidine in HZT-501 will not reduce this risk.

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