tanimilast (CHF6001) / Chiesi - LARVOL DELTA

A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate CHF 6001 (clinicaltrials.gov) - P2 | N=50 | Completed | Sponsor: Chiesi Farmaceutici S.p.A. | Recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Lung Deposition of Tanimilast, an Inhaled Phosphodiesterase-4 Inhibitor, in Patients with Asthma or COPD, Evaluated Using Functional Respiratory Imaging. (PubMed, J Aerosol Med Pulm Drug Deliv) - " Tanimilast effectively reached all levels of the airway in patients with asthma or COPD. Peripheral deposition was enhanced by lower inspiratory flows (i.e., longer inhalation durations), suggesting that specific inhalation strategies may have the potential to improve therapeutic outcomes in obstructive lung diseases."

Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Chiesi Announces Discontinuation of the Tanimilast Program (Chiesi Press Release) - "Chiesi Group today announced its decision to conclude all clinical trials for the tanimilast program in Chronic Obstructive Pulmonary Disease (COPD) and asthma. This decision follows the full analysis of the Phase 3 PILASTER Main Cohort study in COPD, which did not meet its primary and key secondary endpoints. No safety concerns were identified....While this outcome is disappointing, it reflects the complexity of respiratory diseases and the challenges of developing innovative therapies in COPD."

Discontinued • Trial termination • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

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) (clinicaltrials.gov) - P3 | N=3973 | Active, not recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2027 ➔ Dec 2025 | Trial primary completion date: Apr 2027 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Targeting PDE4 to promote lung repair in COPD (ERS 2025) - "Our findings suggest CS may impair the regenerative and differentiation potential of lung epithelial cells through alterations of WNT/β-catenin pathway. Tanimilast-Formoterol combination therapy is promising for rescuing CSE- impaired organoid formation, suggesting it as an effective therapeutic approach for lung repair in COPD."

Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases

Ex-vivo efficacy of tanimilast in human COPD-derived Precision Cut Lung Slices (PCLS) (ERS 2025) - "The obtained results confirm the anti-inflammatory effect of tanimilast in the context of COPD and underline its ability to affect mucus hyperproduction in PCLS derived from COPD patients. This data further consolidates the potential therapeutic role of tanimilast in the treatment of COPD."

Preclinical • Chronic Obstructive Pulmonary Disease • Fibrosis • Immunology • Inflammation • Respiratory Diseases • COL1A1 • MUC5AC • MUC5B

Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Chiesi Farmaceutici S.p.A. | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Jun 2025

Trial completion • Trial completion date • Breast Cancer • Chronic Obstructive Pulmonary Disease • Immunology • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

The inhaled PDE4 inhibitor tanimilast shows a broad anti-inflammatory effect in two mouse models of asthma induced by house dust mite (EAACI 2025) - "When tested in combination with budesonide, tanimilast showed an additional anti-inflammatory effect compared to the steroid or tanimilast alone. Conclusion Overall, these data demonstrate that tanimilast is able to modulate both Th2 and non Th2 inflammation as well as AHR in asthma models including where ICS is not effective, suggesting that it could be a relevant therapy for asthmatic patients poorly controlled by ICS."

Late-breaking abstract • Preclinical • Immunology • Inflammation

Ex-vivo Efficacy of Tanimilast in Human COPD-derived Precision Cut Lung Slices (PCLS) (ATS 2025) - "The obtained results confirm the anti-inflammatory effect of tanimilast in the context of COPD and underline its ability to affect mucus hyperproduction in PCLS derived from COPD patients. This data further consolidates the potential therapeutic role of tanimilast in the treatment of COPD."

Late-breaking abstract • Preclinical • Chronic Obstructive Pulmonary Disease • Fibrosis • Immunology • Inflammation • Respiratory Diseases • COL1A1 • MUC5AC • MUC5B

Lung Deposition of Tanimilast, an Inhaled Phosphodiesterase-4 Inhibitor, Assessed by Functional Respiratory Imaging in Asthma and COPD (ATS 2025) - "Tanimilast reached targeted regions in the lungs in asthma and COPD. Peripheral deposition appeared greater in asthma but in both diseases was enhanced by lower inspiratory flow rates with longer inhalation times. This suggests that inhalation strategies may have the potential to improve therapeutic outcomes in obstructive lung diseases."

Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Evaluating the Impact of Hepatic or Renal Impairment on Tanimilast (CHF6001) Pharmacokinetics: Two Open-Label, Parallel-Group, Single-Center Studies. (PubMed, Clin Transl Sci) - P1 | "These data suggest that the pharmacokinetics of tanimilast are not impacted by mild-to-moderate hepatic impairment, or by mild-to-severe renal impairment. Trial Registration: ClinicalTrials.gov (hepatic impairment NCT05373953; renal impairment NCT05431426) and EudraCT (hepatic impairment 2021-003729-31; renal impairment 2021-005567-43)."

Journal • PK/PD data • Asthma • Chronic Obstructive Pulmonary Disease • Hepatology • Immunology • Pulmonary Disease • Renal Disease • Respiratory Diseases

A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate CHF 6001 (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Chronic Obstructive Pulmonary Disease • Immunology • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

TANGO: Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy (clinicaltrials.gov) - P2 | N=464 | Active, not recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2026 ➔ Feb 2027 | Trial primary completion date: Feb 2025 ➔ Mar 2026

Enrollment closed • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

DDI2: Effect of Cyclosporine Inhibition of Specific P-glycoprotein and Breast Cancer Resistance Protein Transporters on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Chiesi Farmaceutici S.p.A.

New P1 trial • Breast Cancer • Chronic Obstructive Pulmonary Disease • Immunology • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate CHF 6001 (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Chiesi Farmaceutici S.p.A.

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER) (clinicaltrials.gov) - P3 | N=3435 | Active, not recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Jan 2026 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

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) (clinicaltrials.gov) - P3 | N=3980 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Trial completion date: Sep 2027 ➔ Apr 2027 | Trial primary completion date: Sep 2027 ➔ Apr 2027

Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

TANGO: Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy (clinicaltrials.gov) - P2 | N=464 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Feb 2025

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Pharmacokinetics and absorption, distribution, metabolism and excretion profiling of tanimilast following an intravenous 14C-microtracer coadministered with an inhaled dose in healthy male individuals. (PubMed, Drug Metab Dispos) - "Eight male volunteers received a dose of nonradiolabeled tanimilast via Chiesi NEXThaler and a microtracer intravenous dose. Results show pivotal pharmacokinetic results for the characterization of tanimilast, excretion route and quantification of significant metabolites, facilitating streamlined clinical development and regulatory approval."

Journal • PK/PD data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

The need for inhaled phosphodiesterase inhibitors in chronic obstructive pulmonary disease. (PubMed, Expert Rev Clin Pharmacol) - "Tanimilast and ensifentrine have been shown to improve lung function, reduce exacerbations and enhance quality of life in COPD patients. However, it has not yet been determined which type of COPD patient might benefit more from inhaled PDE4 inhibitors, and it remains unclear whether concomitant inhibition of PDE3 and PDE4 confers a significant benefit compared to blocking PDE4 alone in COPD."

Journal • Review • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Anti-inflammatory effects of tanimilast in two murine house dust mite (HDM)-driven models of asthma (BTS WM 2024) - P2, P3 | "When tested on top of budesonide, tanimilast at 1mg/kg showed an additional anti-inflammatory effect compared to the steroid alone both on the EOS count (85% vs 31%, p<0.001) and on the Th2 cytokines. Conclusion Overall, these data demonstrate that tanimilast is able to modulate both Th2 and non Th2 inflammation as well as AHR in asthma models including where ICS is not effective, suggesting that it could be a relevant therapy for asthmatic patients poorly controlled by ICS."

Preclinical • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Pharmacokinetics, safety and tolerability of tanimilast following single administration in subjects with mild, moderate and severe renal impairment (BTS WM 2024) - "Conclusion The systemic exposure of tanimilast was comparable in subjects with mild, moderate, and severe RI and matched HVs. Tanimilast 800 µg DPI was safe and well tolerated in subjects across all stages of RI in comparison to matching HVs."

Clinical • PK/PD data • Chronic Obstructive Pulmonary Disease • Hypotension • Immunology • Nephrology • Pain • Renal Disease • Respiratory Diseases

Pharmacokinetics, safety and tolerability of tanimilast following single administrations in subjects with mild, moderate and severe hepatic impairment (BTS WM 2024) - "A 2-fold increase in systemic exposure was observed in subjects with severe HI. Overall, adverse event AE rate was low and similar between HI groups and HV."

Clinical • PK/PD data • Chronic Obstructive Pulmonary Disease • Hepatology • Immunology • Pain • Respiratory Diseases

Pharmacokinetics and ADME Profiling of Tanimilast Following an Intravenous 14C-Microtracer co-administered with an Inhaled Dose in Healthy Male Individuals. (PubMed, Drug Metab Dispos) - "Eight male volunteers received a dose of non-radiolabeled tanimilast via NEXThaler® and a microtracer IV dose. Results show pivotal PK results for the characterization of tanimilast, excretion route and quantification of significant metabolites, facilitating streamlined clinical development and regulatory approval."

Journal • PK/PD data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases