Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GTX-104 · 2 trials · 2 indications
Hypotension events requiring medical treatment
Maximum concentration
Area under the concentration-time curve
| Arm | Type | Description |
|---|---|---|
| GTX-104 | EXPERIMENTAL | GTX-104 is a sterile concentrate of 10 mg nimodipine/5 mL (2 mg/mL), to be diluted in normal saline to obtain a dosing solution composed of dispersed micelles containing nimodipine for IV infusion. It will be administered as a continuous IV infusion of 0.15 mg/hour and a 30-minute IV bolus of 4 mg every 4 hours for up to 21 days |
| Oral nimodipine | ACTIVE_COMPARATOR | Oral nimodipine is a soft gelatin capsule. The dose is 60 mg (two 30 mg capsules) every 4 hours for up to 21 consecutive days. |
| Treatment A (GTX-104 IV, Test): | EXPERIMENTAL | Nimodipine was administered by infusion over 72 hours. |
| Treatment B (NIMOTOP, RLD): | EXPERIMENTAL | Nimodipine capsules (RS) administered orally with 240 mL of water at a dose level of 60 mg (two 30 mg capsules) q4h for 72 hours. |
| Name | Type | Description |
|---|---|---|
| GTX-104 | DRUG | Nimodipine IV infusion |
| Nimotop 30 MG Oral Capsule | DRUG | Oral nimodipine capsules |
| Nimodipine Capsules | DRUG | Nimodipine capsules (reference formulation) |
Inclusion Criteria: 1. Male or female ≥18 years of age. 2. Diagnosis of aneurysmal subarachnoid hemorrhage (aSAH) based on CT scan and angiography (computed tomography angiography \[CTA\], magnetic resonance angiography \[MRA\], or digital subtraction angiography \[DSA\]). 3. Hunt and Hess score fr...
GTX-104 is being developed for aneurysmal subarachnoid hemorrhage, a type of bleeding around the brain. It is an investigational small molecule therapy in Phase 3 development. Grace Therapeutics holds an orphan drug designation from the FDA for this program.
GTX-104 is developed by Grace Therapeutics, Inc., which trades under the ticker GRCE. The company is running the clinical program for the drug in aneurysmal subarachnoid hemorrhage, including a Phase 3 trial in the United States and a completed Phase 1 study in Canada.
GTX-104 is in Phase 3 clinical development. Its Phase 3 trial, NCT05995405, is active and not currently recruiting, while an earlier Phase 1 bioavailability study, NCT05418348, has been completed. The drug is investigational and has not been approved by the FDA.
GTX-104 has been studied in two clinical trials. NCT05995405 is a Phase 3 safety and tolerability study comparing GTX-104 with oral nimodipine in patients with aneurysmal subarachnoid hemorrhage, with 100 patients enrolled in the United States. NCT05418348 was a completed Phase 1 relative bioavailability study in 58 healthy subjects in Canada.
GTX-104 is not approved; it remains an investigational drug in Phase 3 clinical development for aneurysmal subarachnoid hemorrhage. The FDA has granted it orphan drug designation, which supports development for this rare condition. Grace Therapeutics is the sponsor of the ongoing program.
GTX-104 is an intravenous formulation studied against oral nimodipine capsules. The Phase 3 trial NCT05995405 compares GTX-104 with oral nimodipine in patients with aneurysmal subarachnoid hemorrhage, and the completed Phase 1 trial NCT05418348 evaluated the relative bioavailability of intravenous GTX-104 versus oral nimodipine in healthy subjects.