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REGN3500 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| REGN3500 | EXPERIMENTAL | REGN3500: masked and randomized dosing regimen per protocol (part 1 only) |
| Dupilumab | EXPERIMENTAL | Dupilumab: masked and randomized dosing regimen per protocol (part 1 only) |
| REGN3500 plus dupilumab | EXPERIMENTAL | REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only) |
| Placebo | EXPERIMENTAL | Placebo: masked and randomized dosing regimen per protocol (part 1 only) |
| Fluticasone propionate | ACTIVE_COMPARATOR | Fluticasone propionate: open label dosing regimen per protocol (part 2 only) |
| Cohort 1 | EXPERIMENTAL | REGN3500 low dose or placebo |
| Cohort 2 | EXPERIMENTAL | REGN3500 medium dose or placebo |
| Name | Type | Description |
|---|---|---|
| REGN3500 | DRUG | Intravenous (IV) use |
| Dupilumab | DRUG | Subcutaneous (SC) use |
| Placebo | DRUG | Matching placebo |
| Fluticasone propionate | DRUG | Inhalation use |
KEY Inclusion Criteria: 1. Male or female aged between 18 and 60 years 2. Has a Body Mass Index {BMI) of 17 to 33 kg/m2 at pre-study screening 3. Has a history of mild allergic asthma for at least 6 months 4. Is a non-smoker or ex-smoker for at least 12 months KEY Exclusion Criteria: 1. Has a his...
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 |
REGN3500 is an investigational small molecule developed by Regeneron Pharmaceuticals for respiratory conditions, specifically asthma and allergic asthma. It has been studied in Phase 1 clinical trials. It is not an approved therapy and remains in early clinical development.
REGN3500 has been studied for the treatment of asthma, including allergic asthma and moderate asthma. Clinical testing has involved adult patients with these conditions. As an investigational agent in Phase 1 development, it is not approved for any use.
REGN3500 is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron sponsored the Phase 1 clinical studies of the compound in patients with asthma.
REGN3500 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one studying REGN3500 with dupilumab in asthma patients and one studying multiple ascending doses in adults with moderate asthma. It is investigational and not approved.
REGN3500 has been evaluated in two completed Phase 1 trials: NCT03112577, which studied REGN3500 and dupilumab in patients with asthma and allergic asthma, and NCT02999711, which studied safety, tolerability, and pharmacokinetics of multiple ascending doses in adults with moderate asthma.
The REGN3500 Phase 1 program enrolled 32 participants in NCT03112577 and 23 participants in NCT02999711. Both were randomized, double-blind, controlled studies conducted in the United States and the United Kingdom in adults aged 18 years and older.