Grace Therapeutics Secures New U.S. Patent For GTx-104, Extending IP Protection To 2043

Grace Therapeutics, Inc., a late-stage biopharmaceutical company developing innovative therapies for neurological conditions, announced that the U.S. Patent and Trademark Office has issued a new patent (No. 12,414,943) covering its investigational therapy GTx-104. The patent, titled “Nimodipine Parenteral Administration” and published on September 16, 2025, protects the intravenous dosing regimen of nimodipine used in Grace’s ongoing Phase 3 STRIVE-ON safety trial.

The company has built a strong intellectual property portfolio around GTx-104, its novel injectable formulation of nimodipine designed for intravenous infusion in patients with aneurysmal subarachnoid hemorrhage (aSAH). Grace already holds five patents on the composition of its nimodipine formulation, which extend protection until 2037. With the new method-of-use patent, the company’s exclusivity now stretches through 2043.

“We conducted extensive clinical work with our innovative GTx-104 formulation and dosing regimen and established the scientific bridge to oral nimodipine. With patent coverage on the dosing regimen that would be included in the label for GTx-104, if approved by the FDA, we have added a new layer and extended the duration of protection on the proprietary work completed in our pharmacokinetic studies and the Phase 3 STRIVE-ON safety trial. We believe that if our NDA for GTx-104 is approved by the FDA, our strong U.S. and international patent estate will help to maximize the long-term market value of GTx-104 and correspondingly deliver value for our shareholders,” said Prashant Kohli, Chief Executive Officer of Grace Therapeutics. 

In addition to patent protections, GTx-104 has been granted Orphan Drug Designation by the U.S. FDA, securing seven years of market exclusivity following regulatory approval of a New Drug Application (NDA). Together, these protections reinforce Grace Therapeutics’ position as it advances GTx-104 through late-stage development to address critical unmet medical needs in aSAH treatment.