Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RPL554 plus tiotropium · 1 trial · 1 indication
Peak forced expired volume in 1 second (FEV1) over 4 hours on the third day of dosing
Average FEV1 area under the curve (AUC) over 12 hours on the third day of dosing
| Arm | Type | Description |
|---|---|---|
| Lower Dose Nebulised Treatment | EXPERIMENTAL | 1.5 mg nebulised RPL554 twice daily plus 10 mcg tiotropium DPI once daily for 3 days |
| Higher Dose Nebulised Treatment | EXPERIMENTAL | 6 mg nebulised RPL554 twice daily plus 10 mcg tiotropium DPI once daily for 3 days |
| Placebo | PLACEBO_COMPARATOR | Nebulised RPL554 matched placebo twice daily plus 10 mcg tiotropium DPI once daily for 3 days |
| Name | Type | Description |
|---|---|---|
| 1.5 mg RPL554 plus tiotropium | DRUG | - |
| 6 mg RPL554 plus tiotropium | DRUG | - |
| Placebo plus tiotropium | DRUG | - |
Inclusion Criteria: 1. Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study. 2. Male or female aged between 40 and 75 years inclusive, at the time of informed consent. 3. If male: must agree to ...
RPL554 is an investigational small molecule being developed for respiratory conditions including COPD, asthma, cystic fibrosis, and inflammatory disorders of the respiratory tract. It is currently in Phase 2 clinical development and is not approved by the FDA.
RPL554 is being studied for use in chronic obstructive pulmonary disease (COPD), including moderate COPD. Clinical trials have evaluated its bronchodilator effects when added to other COPD treatments such as tiotropium and tiotropium/olodaterol.
RPL554 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting Phase 2 clinical trials of the drug for respiratory indications.
RPL554 is in Phase 2 clinical development. All completed trials for the drug are Phase 2 studies, and the drug remains investigational, meaning it has not received FDA approval.
RPL554 has been studied in several Phase 2 trials, including NCT02919995 in cystic fibrosis patients, NCT03028142 in COPD patients on tiotropium, NCT03443414 as a dose-ranging study in COPD, and NCT03673670 in COPD patients on tiotropium/olodaterol. All trials are completed.
RPL554 is not known to have alternative names. It is a distinct investigational small molecule being developed by Merck & Company, Inc. for respiratory conditions.