Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DESF · 2 trials · 1 indication
Baseline Corrected Maximum Epinephrine Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 10 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 20 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 30 minutes
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 45 minutes
| Arm | Type | Description |
|---|---|---|
| Single Doses of DESF and Intramuscular Manual Injection | EXPERIMENTAL | Single dose of DESF (12 mg) administered after allergen challenge (Treatment Period 1), followed by a single dose of intramuscular (IM) manual injection (0.3 mg) without allergen challenge after a 24-hour washout period (Treatment Period 2), followed by a single dose of DESF (12 mg) without allergen challenge after a 14-day washout period from Treatment Period 1. |
| Repeat Doses of DESF and Intramuscular Manual Injection | EXPERIMENTAL | Repeat dose of DESF (24 mg \[12 mg x 2\]) administered after allergen challenge (Treatment Period 1), followed by a repeat dose of IM manual injection (0.6 mg \[0.3 mg x 2\]) without allergen challenge after a 24-hour washout period (Treatment Period 2), followed by a repeat dose of DESF (24 mg \[12 mg x 2\]) without allergen challenge after a 14-day washout period from Treatment Period 1. |
| Single Dose of DESF | EXPERIMENTAL | A single dose (12 mg) of DESF administered. |
| Name | Type | Description |
|---|---|---|
| DESF | DRUG | DESF administered in the sublingual space. |
| Epinephrine Injection | DRUG | Epinephrine manual injection administered intramuscularly according to the approved prescribing information. |
Inclusion Criteria: * Willing and able to provide written informed consent and capable of following the protocol-required guidelines. * Healthy males and females 18 through 55 years of age. * Body weight ≥50 kg for males and ≥45 kg for females. * BMI ≥18 kg/m2 to ≤32 kg/m2. * Known history of oral ...
DESF is an investigational small molecule being developed for the treatment of allergic reactions, including oral allergy syndrome. It is currently in clinical development and has not been approved by the FDA. Studies have been conducted in adults and pediatric subjects to evaluate its pharmacokinetics, pharmacodynamics, and safety.
DESF is being developed by Aquestive Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AQST. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with allergic reactions.
DESF is in Phase 2 clinical development. Two clinical trials have been completed, including a Phase 2 study in adults with oral allergy syndrome and a Phase 1 study in pediatric subjects. The drug remains investigational and is not yet approved for commercial use.
DESF has been studied in two completed clinical trials. NCT06527937 was a Phase 2 pharmacokinetics study in 36 adults with oral allergy syndrome in the United States. NCT07703982 was a Phase 1 study evaluating pharmacokinetics, pharmacodynamics, and safety in 32 pediatric subjects aged 7 years and older in the United States and Canada.
DESF is a small molecule designed to treat allergic reactions. Its specific molecular target has not been disclosed in available information. Clinical trials have focused on evaluating its pharmacokinetics, pharmacodynamics, and safety in patients with allergic conditions, including oral allergy syndrome.