| Quantity: | |
|---|---|
Nerandomilast is an orally active, preferential phosphodiesterase 4B (PDE4B) inhibitor developed for the management of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in adult patients. As a novel antifibrotic and immunomodulatory agent, Nerandomilast offers a distinct therapeutic mechanism relative to existing antifibrotic therapies and represents an important advancement in the treatment landscape of chronic fibrosing lung diseases.
Nerandomilast exerts its pharmacological activity through preferential inhibition of the PDE4B isoenzyme, which regulates intracellular cyclic adenosine monophosphate (cAMP) levels in inflammatory and structural cells. By inhibiting PDE4B, Nerandomilast reduces the expression of pro‑fibrotic growth factors and inflammatory cytokines involved in lung tissue fibrosis, thereby slowing the decline in lung function associated with pulmonary fibrosis. This mechanism produces both anti‑inflammatory and antifibrotic effects with improved tolerability compared to non‑selective PDE4 inhibitors.
Dual Antifibrotic and Immunomodulatory Profile – Exhibits targeted modulation of fibrosis and inflammation pathways, addressing core drivers of IPF and PPF progression.
Preferential PDE4B Inhibition – Specificity for the PDE4B subtype improves tolerability while preserving therapeutic efficacy.
Orally Bioavailable API – Suitable for formulation into convenient oral dosage forms for chronic treatment regimens.
Clinical Evidence‑Backed Efficacy – In pivotal Phase III clinical trials, Nerandomilast significantly slowed the decline in forced vital capacity (FVC), a key measure of lung function, versus placebo over 52 weeks.
Nerandomilast is indicated for use in adult patients with:
Idiopathic Pulmonary Fibrosis (IPF) – A progressive, life‑limiting interstitial lung disease characterized by scarring and declining lung function; Nerandomilast demonstrated statistically significant reduction in FVC decline in the Phase III FIBRONEER‑IPF trial.
Progressive Pulmonary Fibrosis (PPF) – A severe form of fibrosing interstitial lung disease where scarring continues despite conventional therapy; Nerandomilast slowed lung function decline in the Phase III FIBRONEER‑ILD trial compared with placebo.
This therapeutic profile supports Nerandomilast’s role as a distinctive API option for formulation into prescription products targeting chronic fibrotic lung diseases.
Complementary Mechanism – Provides a mechanistically distinct option compared to existing antifibrotic therapies such as nintedanib and pirfenidone.
Potential Combination Use – Clinical data suggest Nerandomilast can be administered with or without other antifibrotics without compromising tolerability.
Improved Tolerability Profile – Selectivity for PDE4B may reduce side effects associated with non‑selective PDE4 inhibition.
Nerandomilast (marketed as Jascayd®) has received regulatory approvals in major markets for the management of IPF and PPF, representing meaningful progress in addressing unmet needs in pulmonary fibrosis care. In the United States, the U.S. Food and Drug Administration (FDA) has approved Jascayd for the treatment of both IPF and PPF in adult patients, marking Nerandomilast as the first preferential PDE4B inhibitor with both antifibrotic and immunomodulatory effects to achieve this milestone.
As an Active Pharmaceutical Ingredient (API), Nerandomilast is supplied as a high‑purity powder suitable for formulation into prescription products such as orally administered tablets. The API is manufactured under robust quality control systems aligned with global regulatory expectations and major pharmacopeial standards. Detailed regulatory dossiers and chemistry, manufacturing, and controls (CMC) documentation support your product development and registration pathways.
Nerandomilast’s novel mechanism, regulatory approvals, and clinical efficacy make it a compelling API choice for pharmaceutical companies developing next‑generation treatments for pulmonary fibrosis. Its roles include:
Active ingredient in chronic interstitial lung disease treatment formulations
Strategic API positioning for combination therapy pipelines
Enhanced product portfolios targeting high unmet medical needs
Nerandomilast is an orally active, preferential phosphodiesterase 4B (PDE4B) inhibitor developed for the management of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in adult patients. As a novel antifibrotic and immunomodulatory agent, Nerandomilast offers a distinct therapeutic mechanism relative to existing antifibrotic therapies and represents an important advancement in the treatment landscape of chronic fibrosing lung diseases.
Nerandomilast exerts its pharmacological activity through preferential inhibition of the PDE4B isoenzyme, which regulates intracellular cyclic adenosine monophosphate (cAMP) levels in inflammatory and structural cells. By inhibiting PDE4B, Nerandomilast reduces the expression of pro‑fibrotic growth factors and inflammatory cytokines involved in lung tissue fibrosis, thereby slowing the decline in lung function associated with pulmonary fibrosis. This mechanism produces both anti‑inflammatory and antifibrotic effects with improved tolerability compared to non‑selective PDE4 inhibitors.
Dual Antifibrotic and Immunomodulatory Profile – Exhibits targeted modulation of fibrosis and inflammation pathways, addressing core drivers of IPF and PPF progression.
Preferential PDE4B Inhibition – Specificity for the PDE4B subtype improves tolerability while preserving therapeutic efficacy.
Orally Bioavailable API – Suitable for formulation into convenient oral dosage forms for chronic treatment regimens.
Clinical Evidence‑Backed Efficacy – In pivotal Phase III clinical trials, Nerandomilast significantly slowed the decline in forced vital capacity (FVC), a key measure of lung function, versus placebo over 52 weeks.
Nerandomilast is indicated for use in adult patients with:
Idiopathic Pulmonary Fibrosis (IPF) – A progressive, life‑limiting interstitial lung disease characterized by scarring and declining lung function; Nerandomilast demonstrated statistically significant reduction in FVC decline in the Phase III FIBRONEER‑IPF trial.
Progressive Pulmonary Fibrosis (PPF) – A severe form of fibrosing interstitial lung disease where scarring continues despite conventional therapy; Nerandomilast slowed lung function decline in the Phase III FIBRONEER‑ILD trial compared with placebo.
This therapeutic profile supports Nerandomilast’s role as a distinctive API option for formulation into prescription products targeting chronic fibrotic lung diseases.
Complementary Mechanism – Provides a mechanistically distinct option compared to existing antifibrotic therapies such as nintedanib and pirfenidone.
Potential Combination Use – Clinical data suggest Nerandomilast can be administered with or without other antifibrotics without compromising tolerability.
Improved Tolerability Profile – Selectivity for PDE4B may reduce side effects associated with non‑selective PDE4 inhibition.
Nerandomilast (marketed as Jascayd®) has received regulatory approvals in major markets for the management of IPF and PPF, representing meaningful progress in addressing unmet needs in pulmonary fibrosis care. In the United States, the U.S. Food and Drug Administration (FDA) has approved Jascayd for the treatment of both IPF and PPF in adult patients, marking Nerandomilast as the first preferential PDE4B inhibitor with both antifibrotic and immunomodulatory effects to achieve this milestone.
As an Active Pharmaceutical Ingredient (API), Nerandomilast is supplied as a high‑purity powder suitable for formulation into prescription products such as orally administered tablets. The API is manufactured under robust quality control systems aligned with global regulatory expectations and major pharmacopeial standards. Detailed regulatory dossiers and chemistry, manufacturing, and controls (CMC) documentation support your product development and registration pathways.
Nerandomilast’s novel mechanism, regulatory approvals, and clinical efficacy make it a compelling API choice for pharmaceutical companies developing next‑generation treatments for pulmonary fibrosis. Its roles include:
Active ingredient in chronic interstitial lung disease treatment formulations
Strategic API positioning for combination therapy pipelines
Enhanced product portfolios targeting high unmet medical needs
