Improving Patient Care & Management

Our lead drug candidate, GTX-104, is a novel injectable formulation of nimodipine for the treatment of a rare disease, aneurysmal subarachnoid hemorrhage (aSAH). This formulation offers several potential advantages over oral administration of nimodipine that is the current Standard of Care (SoC) in the United States.

The Method of Action of GTX-104 Drug Delivery Delivery Technology

  • Novel injectable formulation of nimodipine
  • Overcomes solubility limitations of nimodipine
  • A patented formulation that uses non-ionic surfactant micelles as the drug carrier to solubilize nimodipine
  • Simple to prepare in a pharmacy and stable at room temperature

What is aSAH?

aSAH occurs suddenly and is caused by a ruptured aneurysm that bleeds in the subarachnoid space between the brain and skull.

Immediate surgical and pharmacotherapy intervention is key as the condition deteriorates quickly.

Currently, the only SoC is oral nimodipine therapy indicated for up to 21 days.

GTX-104 represents a potential solution to a sizable patient population and a significant market opportunity


Cases of aSAH annually in the US


Of affected patients under 60 years old


Of aSAH patients die before reaching the hospital


Death/dependence occurs in admitted patients


Total US market

Limits of Current SoC

  • Heavy dosing burden due to high first pass metabolism
  • Poor hypotension management and frequent dose interruption
  • Nasogastric tube delivery in unconscious or dysphagic patients
  • Food effects and contraindicated with CYP3A inhibitors
  • High pharmacokinetic variability with oral route

As a novel IV formulation of nimodipine, GTX-104 is well positioned to potentially solve these challenges.

Superior Value Proposition

GTX-104 is designed to address significant unmet medical needs for patients with aSAH. We believe that with this novel nimodipine IV formulation may offer a potential value to physicians, hospitals, and their patients.

Clinical Value

  • 100% bioavailable for GTX-104 versus only 13% for oral nimodipine
  • Potential for effective hypotension management
  • No food effects and reduced DDI
  • Reduced drug intake
  • Predictable drug concentration

Hospital Value

  • Reduced medication error
  • Reduced nursing burden
  • Reduced rescue therapy use
  • Potentially shortened ICU stay
  • Joint Commission compliance
  • Potentially positive economic impact

Patient Value

  • Potentially safer
  • Potentially improved outcomes
  • Convenient dosing
  • Potential for faster recovery
  • Potential for reduced disease burden

STRIVE-ON Pivotal Phase 3 Safety Trial

GTX-104 is currently being evaluated in the pivotal STRIVE-ON Phase 3 Trial (NCT05995405), a 100-patient, randomized (1:1 ratio) parallel group trial of GTX-104 compared with oral nimodipine in patients hospitalized for aSAH.

Learn More About STRIVE-ON

GTX-104-002 Phase 1 Data

Our Phase 1 results established consistent and predictable results while meeting all primary and secondary endpoints. Phase 1 consisted of randomized, two-period crossover trial evaluating the bioavailability of IV GTX-104 compared to oral nimodipine capsules.

Phase 1 Trial Successes and Conclusions

  • GTX-104 is 100% bioavailable versus 7.20% for oral
  • Significant lower dose variability
  • Predicable and consistent plasma concentrations
  • Demonstrated improved or comparable hypotension
  • Strong safety profile with no serious adverse events

Comprehensive Intellectual Property Portfolio

GTX-104 has been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States. Our IP patents extend beyond the exclusivity of the orphan drug designation and consists of composition and method-of-use patents.

We have five patents granted in the United States with multiple across the world.


Dive deeper into our work in developing GTX-104 via our publications.

Read Publications


If you are interested in partnering with us, please contact us.

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Additional Candidates

Explore other candidates in our pipeline that focus on Ataxia Telangiectasia (A-T), and Postherpetic Neuralgia (PHN).

View Our Pipeline