Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
epinephrine · 1 trial · 1 indication
Change in itch and hive scores (Uniform Assessment System) \[UAS\] 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 for the treatment of chronic spontaneous urticaria, a condition characterized by recurrent hives. It is administered as a 0.5 mg dose and is currently in Phase 2 clinical development. The drug is being evaluated in an outpatient study to assess its efficacy in patients with this condition.
Epinephrine is a small molecule that acts as a non-selective agonist of alpha and beta adrenergic receptors. In the context of chronic urticaria, it is believed to work by causing vasoconstriction and reducing vascular permeability, which may help alleviate the symptoms of hives. However, the exact mechanism in this indication is still under investigation.
Epinephrine is being developed by ARS Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SPRY. The company is conducting clinical trials to evaluate the drug's efficacy in patients with chronic spontaneous urticaria.
Epinephrine is currently in Phase 2 clinical development for the treatment of chronic urticaria. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is recruiting participants to evaluate the drug's efficacy and safety in this patient population.
Epinephrine is being studied in a Phase 2 clinical trial with the identifier NCT06927999. The trial, titled 'An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria,' is recruiting participants in the United States and Germany. The study is randomized, double-blind, and placebo-controlled, with an enrollment target of 42 patients aged 18 years and older.
Yes, epinephrine is also known as 0.5 mg epinephrine, referring to the specific dose being studied in the clinical trial. The drug is being evaluated at this dose in patients with chronic spontaneous urticaria. This naming convention helps distinguish the specific formulation and dosage used in the ongoing Phase 2 study.