Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GX-03 · 2 trials · 4 indications
vIGA-AD Success defined as score of 0 (clear) or 1 (almost clear) with a ≥2-grade improvement from baseline at Week 4. All Primary Outcome measures will be evaluated using the Hochberg-method.
75% reduction from baseline in Eczema Area Severity Index (EASI) at Week 4. All Primary Outcome measures will be evaluated using the Hochberg-method.
90% reduction from baseline in Eczema Area Severity Index (EASI) at Week 8. All Primary Outcome measures will be evaluated using the Hochberg-method.
100% reduction from baseline in Eczema Area Severity Index (EASI) at Week 8. All Primary Outcome measures will be evaluated using the Hochberg-method.
Time to achieve a 60% reduction in viral load from baseline.
To evaluate the incidence rate(s) of non-serious and serious adverse events associated with administration of the study product.
| Arm | Type | Description |
|---|---|---|
| GX-03 | EXPERIMENTAL | Treatment Arm |
| Vehicle | EXPERIMENTAL | Vehicle Control |
| Treatment of hospitalized patients with laboratory-confirmed COVID-19 | EXPERIMENTAL | Hospitalized patients with laboratory-confirmed COVID-19 using GX-03 administered intranasally TID for 5 days. |
| Placebo Treatment of hospitalized patients with laboratory-confirmed COVID-19 | PLACEBO_COMPARATOR | Hospitalized patients with laboratory-confirmed COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 5 days. |
| Prevention of SARS-COV-2 in Health Care Providers | EXPERIMENTAL | Health care providers with laboratory-confirmed negative COVID-19 using GX-03 administered intranasally TID for 10 days. |
| Placebo Prevention of SARS-COV-2 in Health Care Providers | PLACEBO_COMPARATOR | Health care providers with laboratory-confirmed negative COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 10 days. |
| Name | Type | Description |
|---|---|---|
| GX-03 | COMBINATION_PRODUCT | Topical ointment |
| Vehicle | OTHER | Ointment carrier |
| Petrolatum ointment | DRUG | Viscous ointment similar in form to study drug. |
Participants must meet all of the following criteria: * Adults aged 18 to 80 years, inclusive * Male or female subjects in good general health as determined by medical history * Subjects meeting all of the following baseline criteria: * Baseline EASI Score of ≥ 1.1 * Baseline vIGA-AD Score of ...
GX-03 is an investigational small molecule being studied for the treatment and prevention of COVID-19 and for moderate to severe atopic dermatitis (eczema). It is administered intranasally for COVID-19 and is being evaluated in a topical formulation for eczema. GX-03 is not yet approved and remains in clinical development.
The specific molecular target of GX-03 is not disclosed in available information. It is a small molecule being developed by Turn Therapeutics Inc. for infectious disease and dermatology indications. Clinical trials are evaluating its safety and efficacy in COVID-19 and atopic dermatitis, but its mechanism of action has not been publicly detailed.
GX-03 is being developed by Turn Therapeutics Inc., a biopharmaceutical company. The company is conducting clinical trials for GX-03 in COVID-19 and atopic dermatitis. Turn Therapeutics Inc. is publicly traded under the ticker TTRX.
GX-03 is in Phase 2 clinical development. It has completed a Phase 2 trial for COVID-19 and is currently recruiting participants for a Phase 2 trial in atopic dermatitis. GX-03 is investigational and has not received FDA approval.
GX-03 has one completed Phase 2 trial, NCT04951349, which studied intranasal GX-03 for COVID-19 treatment and prevention in Panama with 85 participants. An ongoing Phase 2 trial, NCT07355075, is recruiting 190 adults in the United States with moderate to severe atopic dermatitis.
No alternative names for GX-03 have been reported. It is referred to solely as GX-03 in clinical trial registrations and by its developer, Turn Therapeutics Inc. Patients and researchers should use the name GX-03 when searching for information about this investigational drug.