tanimilast: Clinical Trials

6 completed, 1 terminated. 4 Phase 1, 2 Phase 2, 1 Phase 3.

By phase and status

Phase	Trials	Status
Phase 1	4	Completed 4
Phase 2	2	Completed 2
Phase 3	1	Terminated 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Clinical Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Liver Impairment in Comparison With Matched Healthy Control Subjects CHF6001 - Chronic Obstructive Pulmonary Disease	Phase 1	Completed	Chiesi Farmaceutici S.p.A.	44	2022-05-05	2024-04-15
A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR) CHF6001 1600µg, CHF6001 3200µg, Placebo - Chronic Obstructive Pulmonary Disease	Phase 3	Terminated	Chiesi Farmaceutici S.p.A.	3973	2021-07-12	2026-02-02
Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast) in Healthy Subjects CHF6001 - Chronic Obstructive Pulmonary Disease (COPD), COPD	Phase 1	Completed	Chiesi Farmaceutici S.p.A.	8	2021-03-10	2024-03-18
A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD CHF6001, Budesonide, Placebo - Chronic Obstructive Pulmonary Disease	Phase 2	Completed	Chiesi Farmaceutici S.p.A.	1130	2016-12-15	2019-01-28
Pharmacokinetic Interaction and the Safety of Inhaled CHF5259 and CHF6001 CHF5259 and CHF6001, CHF5259 + placebo, CHF6001 + placebo - Copd	Phase 1	Completed	Chiesi Farmaceutici S.p.A.	36	2016-01-01	2016-12-29
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001 Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) - Chronic Obstructive Pulmonary Disease	Phase 1	Completed	Chiesi Farmaceutici S.p.A.	48	2014-11-01	2020-07-31
A Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Inhaled CHF6001 DPI in Asthmatics CHF6001, Placebo - Asthma	Phase 2	Completed	Chiesi Farmaceutici S.p.A.	36	2012-10-01	2017-03-30

Conditions studied

Pulmonary Disease, Chronic Obstructive (6)  ·  Asthma (1)  ·  Bronchitis, Chronic (1)

Sponsors

Chiesi Farmaceutici S.p.A. (7)

Countries

United Kingdom (5)  ·  Bulgaria (2)  ·  Argentina (1)  ·  Austria (1)  ·  Bosnia and Herzegovina (1)  ·  Chile (1)  ·  Croatia (1)  ·  Czechia (1)  ·  Estonia (1)  ·  Germany (1)  ·  Greece (1)  ·  Hungary (1)  ·  Israel (1)  ·  Latvia (1)  ·  Mexico (1)

Top investigators

Brian Leaker, MD (1)  ·  Dave Singh (1)  ·  Dave Singh, MD (1)  ·  Elizabeth Tranter, MD (1)  ·  Ronnie Beboso, MD (1)  ·  Stuart Mair, MD (1)

Results publications

PMID 30425469, PMID 32962709, PMID 37192443, PMID 40391696

NIH funding

2015 (1), 2023 (1)