Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ARS-1, Adrenaline
ARS-1 with URTI · 3 trials · 3 indications
Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)
Assess time to effect and duration of effect on acute flares associated with urticaria based on a patient reported pruritus/hive score, from 0 (none) to 3 (severe) for itch and hive using Uniform Assessment System (UAS) as below: Severity Score Amount of Itch Itch Severity 0 None None 1. Mild Easily tolerated 2. Moderate Bothersome but tolerable 3. Intense Difficult to tolerate Hive Severity Score Number of Hives 0 None 1. 1-6 2. 7-12 3. \>12
Blood samples will be collected to measure plasma concentrations of adrenaline
Blood samples will be collected to measure plasma concentrations of adrenaline
Blood samples will be collected to measure plasma concentrations of adrenaline
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | ACTIVE_COMPARATOR | ARS 2mg: albuterol: Placebo: ARS 1mg |
| Sequence 2 | ACTIVE_COMPARATOR | ARS 1mg: Placebo: albuterol: ARS 2mg |
| ARS-1 with URTI | EXPERIMENTAL | ARS-1 with URTI |
| ARS-1 without URTI | EXPERIMENTAL | ARS-1 without URTI |
| Name | Type | Description |
|---|---|---|
| ARS-1 1 mg | DRUG | ARS-1 1 mg |
| Albuterol MDI | DRUG | 180 mcg |
| Placebo | DRUG | Placebo |
| ARS-1 2mg | DRUG | ARS-1 2mg |
| ARS-1 | DRUG | A single treatment of ARS-1 1mg, 2 mg or placebo |
| ARS-1 with URTI | DRUG | ARS-1 |
| ARS-1 without URTI | DRUG | ARS-1 without URTI |
Inclusion Criteria: * 1\. Is a male or female subject between the ages of 12 and 65 years, inclusive. * 2\. Asthma that has been stable for at least four weeks prior to screening as defined by clinical history. * 3\. Reversible bronchoconstriction. * 4\. Has body weight more than 30 kilogram (kg) a...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
ARS-1 with URTI refers to the investigational use of ARS-1, an intranasal epinephrine product, studied in people with upper respiratory tract infection. It is being developed by ARS Pharmaceuticals, Inc. (ticker: SPRY) as a small molecule for respiratory conditions including asthma, upper respiratory tract infection, and urticaria.
ARS-1 is being studied for asthma, upper respiratory tract infection, and urticaria. It is an investigational intranasal epinephrine product in Phase 2 development. It has not been approved for any indication and remains in clinical testing by ARS Pharmaceuticals, Inc. (SPRY).
ARS-1 with URTI is being developed by ARS Pharmaceuticals, Inc., which trades under the ticker SPRY. The company is the sponsor of the clinical trials evaluating ARS-1 in asthma, upper respiratory tract infection, and urticaria.
ARS-1 with URTI is in Phase 2 development. The Phase 2 trials have been completed, and a Phase 1 pharmacokinetic trial in upper respiratory tract infection has also been completed. It is an investigational product and has not been approved by the FDA.
ARS-1 with URTI has been evaluated in completed clinical trials, including NCT05496465 in urticaria, NCT05363670 in persistent asthma, and NCT04930900 in upper respiratory tract infection. These trials enrolled 21, 18, and 15 participants, respectively, and were conducted in the United States and Australia.
Yes, ARS-1 with URTI is the same as ARS-1, also known as ARS-1 1 mg. The "with URTI" designation refers to its study in subjects with upper respiratory tract infection. It is an investigational intranasal epinephrine product developed by ARS Pharmaceuticals, Inc. (SPRY).