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MGR001 · 2 trials · 2 indications
CRC749 inhaler robustness will be assessed by in vitro testing of the CRC749 inhaler after 3 weeks of patient use of the MGR001 product.
| Arm | Type | Description |
|---|---|---|
| MGR001 | EXPERIMENTAL | MGR001 (FP/Salmeterol) (250/50 µg) twice daily (BID) |
| Advair® Diskus® | EXPERIMENTAL | FP/SAL 250/50 µg 3 x inhalations (total dose 750/150 µg) administered via Diskus® inhaler. |
| Seretide™ Accuhaler™ | EXPERIMENTAL | FP/SAL 250/50 µg 3 x inhalations (total dose 750/150 µg) administered via Accuhaler™ inhaler. |
| Name | Type | Description |
|---|---|---|
| MGR001 | DRUG | Fluticasone Propionate / Salmeterol administered using CRC749 inhaler |
| CRC749 inhaler | DEVICE | - |
| Advair® Diskus® | DRUG | Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA) |
| Seretide™ Accuhaler™ | DRUG | Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA) |
Inclusion Criteria: 1. Males and females at least 12 years of age. 2. A clinical diagnosis for at least 12 weeks prior to screening of asthma or COPD and stable treatment. 3. Spirometry following salbutamol showing FEV1 ≥40% of predicted normal and FEV1/FVC ratio \<0.7 for COPD subjects. 4. Spirome...
MGR001 is an investigational small molecule being developed for the treatment of asthma. It is in Phase 1 clinical development and has been studied in patients with asthma and COPD. The drug is not yet approved and remains under clinical investigation.
MGR001 is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in respiratory conditions.
MGR001 is currently in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 151 participants. The drug is investigational and has not received regulatory approval.
MGR001 has been studied in two completed Phase 1 trials: NCT02215122, a bioequivalence study of fluticasone propionate and salmeterol from different dry powder inhalers in healthy volunteers, and NCT02474017, an open study assessing the robustness of the CRC749 inhaler in patients with asthma and COPD.
MGR001 is a fixed-dose combination product containing fluticasone propionate and salmeterol, as indicated by the bioequivalence study NCT02215122. It is delivered via a dry powder inhaler and is being developed for asthma and COPD.