Ensifentrine

also known as RPL554

Developed for: chronic obstructive pulmonary disease · asthma · bronchiectasis · cystic fibrosis · COVID-19
Investigated by: Verona Pharma, Inc. · IQVIA Pty Ltd · Nuance Pharma (shanghai) Co., Ltd · Cystic Fibrosis Trust · LGC Limited · Laboratory Corporation of America
+2 more
· Midwest Chest Consultants · University of Alabama at Birmingham

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	US (FDA)	OHTUVAYRE	—	2024-06-26	fda.gov ↗

Trials 18 · a red edge is where a trial was stopped

today

US approved 2024

NCT07132983 · Ph 2 NCT07016412 · Ph 2 NCT06559150 · Ph 2 NCT06460493 · Ph 3 NCT05743075 · Ph 3 NCT05758428 · Ph 1 NCT05270525 · Ph 2 NCT04535986 · Ph 3 NCT04542057 · Ph 3 NCT03937479 · Ph 2 NCT04091360 · Ph 2 NCT03673670 · Ph 2 NCT03443414 · Ph 2 NCT02919995 · Ph 2 NCT03028142 · Ph 2 NCT02542254 · Ph 2 NCT02427165 · Ph 2 NCT02307162 · Ph 1

20152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 12 trials
Phase 1	NCT05758428	Mar → Apr 2023	chronic obstructive pulmonary disease	Nuance Pharma (shanghai) Co., Ltd	Completed	No outcome recorded
Phase 1	NCT02307162	Dec 2014 → Jul 2015	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Completed	No outcome recorded
Phase 212 trials
Phase 2	NCT07132983	Oct → Nov 2025	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Completed	No outcome recorded
Phase 2	NCT07016412	Jul 2025 → Aug 2026 overdue	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Recruiting	No outcome recorded
Phase 2	NCT06559150	Sep 2024 → Sep 2027 expected	bronchiectasis	Verona Pharma, Inc.	Recruiting	No outcome recorded
Phase 2	NCT05270525	May 2022 → Dec 2026 expected	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Recruiting	No outcome recorded
Phase 2	NCT03937479	May → Nov 2019	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Completed	No outcome recorded
Phase 2	NCT04091360	Apr 2019 → Dec 2020	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Completed	No outcome recorded
Phase 2	NCT03673670	Jul → Nov 2018	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Completed	No outcome recorded
Phase 2	NCT03443414	Jun 2017 → Jan 2018	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Completed	No outcome recorded
Phase 2	NCT02919995	Feb → Nov 2017	cystic fibrosis	Verona Pharma, Inc.	Completed	No outcome recorded
Phase 2	NCT03028142	Jan → Aug 2017	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Completed	No outcome recorded
Phase 2	NCT02542254	Oct → Dec 2015	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Completed	No outcome recorded
Phase 2	NCT02427165	Apr → Nov 2015	asthma	Verona Pharma, Inc.	Completed	No outcome recorded

Phase 34 trials
Phase 3	NCT06460493	Jun → Nov 2024	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Completed	No outcome recorded
Phase 3	NCT05743075	Mar 2023 → Dec 2024	chronic obstructive pulmonary disease	Nuance Pharma (shanghai) Co., Ltd	Completed	No outcome recorded
Phase 3	NCT04535986	Sep 2020 → Sep 2022	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Completed	No outcome recorded
Phase 3	NCT04542057	Sep 2020 → May 2022	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Completed	No outcome recorded

Also used as a comparator or background therapy in 2 trials

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 2	NCT04527471 Comparator	Sep 2020 → Feb 2021	COVID-19	Verona Pharma Inc	Completed	No outcome recorded
Phase 2	NCT04027439 Comparator	Dec 2018 → May 2019	chronic obstructive pulmonary disease	Verona Pharma, Inc.	Completed	No outcome recorded

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 21 sources stand behind the page.

Field	Value	Cited text
Known as	ensifentrine	“INTRODUCTION: This study aimed to investigate the dose-response and pharmacology of a range of single doses of nebulised ensifentrine (RPL554), an inhaled dual...” PMID 31202957 ↗ Jun 2019 11 NCT05743075 ↗ NCT06460493 ↗ NCT04542057 ↗ NCT07016412 ↗ NCT04527471 ↗ NCT03937479 ↗ NCT04535986 ↗ NCT07132983 ↗ NCT05270525 ↗ NCT06559150 ↗ NCT05758428 ↗
Known as	RPL554	“Ensifentrine (RPL554) 3 mg BID or placebo BID will be administered by aerosol inhalation for 24 weeks; each nebulization time wil be approximately 5 minutes.” NCT05743075 ↗ 10 “Ensifentrine (formerly RPL554) 0.375 mg twice daily plus placebo, in addition to tiotropium” NCT03937479 ↗ NCT04027439 ↗ NCT02307162 ↗ NCT03673670 ↗ NCT03028142 ↗ NCT04091360 ↗ NCT02542254 ↗ NCT02919995 ↗ NCT03443414 ↗ NCT02427165 ↗
Action	Inhibit	“Phosphodiesterase 3 and 4 Inhibitor” NCT02307162 ↗
Route	Inhaled	“Inhaled Doses of RPL554 Administered by Nebuliser” NCT02307162 ↗