Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
epinephrine · 1 trial · 1 indication
Change in itch scores (Uniform Assessment System) - Range is a scale of 0-3. Zero is none and 3 is severe. \[UAS\] as compared to placebo at each timepoint on exacerbation days
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo solution nasal spray containing no active drug will be administered using the commercial sprayer device. |
| 0.5 mg | ACTIVE_COMPARATOR | 0.5 mg epinephrine per spray |
| 1 mg | ACTIVE_COMPARATOR | 1 mg epinephrine per spray |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo solution nasal spray containing no active drug |
| 0.5 mg epinephrine | DRUG | 0.5 mg epinephrine per spray |
| 1 mg epinephrine | DRUG | 1 mg epinephrine per spray |
Inclusion Criteria: * Is a male or female between the ages of 18 and 65 years, inclusive. * Has been clinically diagnosed with CSU and experiences an acute flare of moderate to severe urticaria symptoms (itch and hive severity UAS score ≥ 2) approximately 1-2 times a month or every other month cons...
Epinephrine is being studied as a treatment for chronic spontaneous urticaria, a condition characterized by recurrent hives. It is an investigational small molecule agonist being developed by ARS Pharmaceuticals, Inc. for this dermatologic indication. The drug is currently in Phase 2 clinical development.
Epinephrine targets multiple adrenergic receptors, including ADRA1A, ADRA2A, ADRB1, ADRB2, ADRA2C, and ADRA1D. It acts as an agonist at these receptors, which are part of the G protein-coupled receptor family. This mechanism is being investigated for its potential effects in chronic urticaria.
ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) is developing epinephrine for chronic spontaneous urticaria. The company is conducting a Phase 2 clinical trial to evaluate the drug's efficacy in this patient population. Epinephrine is a small molecule therapeutic being investigated for this dermatologic condition.
Epinephrine is in Phase 2 clinical development for chronic spontaneous urticaria. It is an investigational drug and has not been approved by regulatory authorities for this indication. The ongoing Phase 2 trial is actively recruiting patients to assess the treatment's efficacy and safety.
Epinephrine is being studied in one Phase 2 clinical trial, NCT06927999, titled "An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria." This randomized, double-blind, placebo-controlled trial is recruiting 42 participants at sites in the United States and Germany.
Epinephrine is also known as 0.5 mg epinephrine and is being studied under the trial name ARS-2. In the context of chronic spontaneous urticaria, ARS-2 refers to the specific formulation of epinephrine being evaluated in the Phase 2 clinical trial NCT06927999.