Drugs / TRANIMILAST
last change Dec 2025 re-read 9 days ago

TRANIMILAST

also known as CHF 6001 · tanimilast · J3.309.618F

Small molecule

Developed for
chronic obstructive pulmonary disease · asthma
Investigated by
Chiesi Farmaceutici S.p.A. · Quintiles, Inc. · SGS S.A.

Trials 17

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 19 trials
Phase 1 NCT06892756 Mar → Jun 2025 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 1 NCT06395610 Mar → Jun 2024 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 1 NCT05431426 Jul → Dec 2022 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 1 NCT05373953 May → Nov 2022 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 1 NCT04756960 Mar → Apr 2021 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 1 NCT04739774 Feb → Apr 2021 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 1 NCT03004495 Jan → Aug 2016 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 1 NCT02386761 Nov 2014 → May 2015 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 1 NCT01703052 Jul 2011 → May 2012 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 26 trials · 1 missed
Phase 2 NCT06900816 Mar → Aug 2025 asthma Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 2 NCT06029595 Nov 2023 → Dec 2025 asthma Chiesi Farmaceutici S.p.A. Terminated No outcome recorded Stop: Business
Phase 2 NCT02986321 Dec 2016 → Oct 2017 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed Missed primary
Phase 2 NCT03004417 Oct 2016 → Dec 2017 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 2 NCT01689571 Oct 2012 → Apr 2013 asthma Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 2 NCT01730404 Oct 2012 → Oct 2013 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT04636801 Jul 2021 → Oct 2025 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Terminated No outcome recorded Stop: Business
Phase 3 NCT04636814 Jul 2021 → Dec 2025 chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Terminated No outcome recorded Stop: Business

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as TRANIMILAST ChEMBL registry synonym — accepted as the source's own label CHEMBL3113974 ↗
Known as CHF 6001 “Safety, tolerability, and pharmacokinetics of single and repeat ascending doses of CHF6001, a novel inhaled phosphodiesterase-4 inhibitor: two randomized trials in healthy volunteers.” PMID 30425469 ↗ Oct 2018
19

“Evaluating the Impact of Hepatic or Renal Impairment on Tanimilast (CHF6001) Pharmacokinetics: Two Open-Label, Parallel-Group, Single-Center Studies.” PMID 40391696 ↗ May 2025

“The purpose of this study is to evaluate the amount of the study drug, CHF6001, in the blood of adolescent patients with asthma” NCT06900816 ↗

“CHF6001 is a novel inhaled phosphodiesterase-4 inhibitor.” PMID 31399091 ↗ Aug 2019

“CHF6001, an inhaled phosphodiesterase-4 inhibitor” PMID 30425469 ↗ Oct 2018

“28-day Inhaled CHF 6001 DPI (1200 µg Daily)” NCT01730404 ↗

NCT03004495 ↗

NCT06900816 ↗

NCT06395610 ↗

NCT04636814 ↗

NCT02986321 ↗

Show 9 more sources

Known as J3.309.618F ChEMBL registry synonym — accepted as the source's own label CHEMBL3113974 ↗
Known as tanimilast “The purpose of this study is to evaluate the efficacy and safety of CHF6001 (Tanimilast) as add-on to maintenance of inhaled corticosteroids in combination with Long-acting...” NCT06029595 ↗
6

“The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.” NCT04636801 ↗

“Tanimilast is an inhaled phosphodiesterase-4 inhibitor in development for chronic obstructive pulmonary disease and asthma.” PMID 40391696 ↗ May 2025

“Tanimilast is an inhaled phosphodiesterase-4 inhibitor in development for chronic obstructive pulmonary disease and asthma.” PMID 40391696 ↗ May 2025

“Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast) in Healthy Subjects” NCT04756960 ↗

“Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy” NCT04636814 ↗

“CHF6001 (Tanimilast)” NCT06892756 ↗

Action Inhibit “CHF6001, a PDE4 inhibitor” NCT01689571 ↗
Modality Small molecule — CHEMBL3113974 ↗
Route Inhaled “when given by inhalation” NCT01689571 ↗