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 an investigational small molecule being developed for aneurysmal subarachnoid hemorrhage (aSAH), a type of stroke caused by bleeding in the space surrounding the brain. It is being studied as a potential treatment for patients with this condition.
GTX-104 is being developed by Grace Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol GRCE.
GTX-104 is in clinical development. It has completed a Phase 1 trial and is currently in a Phase 3 trial for aneurysmal subarachnoid hemorrhage. The drug is not yet approved by the FDA and remains investigational.
GTX-104 has been studied in two clinical trials. NCT05418348 was a Phase 1 study comparing the bioavailability of intravenous GTX-104 to oral nimodipine in healthy subjects. NCT05995405 is an active Phase 3 trial evaluating the safety and tolerability of GTX-104 compared with oral nimodipine in patients with aSAH.
Yes, GTX-104 has received orphan drug designation from the FDA for the treatment of aneurysmal subarachnoid hemorrhage. Orphan drug designation is granted to drugs intended for the treatment of rare diseases affecting fewer than 200,000 people in the United States.
GTX-104 is not the same as nimodipine. It is an investigational drug being compared to oral nimodipine in clinical trials. Nimodipine is an approved calcium channel blocker used to prevent vasospasm following subarachnoid hemorrhage, while GTX-104 is being developed as a potential alternative.