FDA approves Nerandomilast-Jascayd to treat idiopathic pulmonary fibrosis

On October 9, 2025, Boehringer Ingelheim’s Nerandomilast-Jascayd tablets have been approved by the U.S. Food and Drug Administration (FDA) as an oral treatment option for adults with idiopathic pulmonary fibrosis (IPF). Namilast tablets are the first and only phosphodiesterase 4B (PDE4B) priority inhibitor approved in this indication. This represents a new mechanism of action that can exert both anti-fibrotic and immunomodulatory effects, thereby slowing down the decline of lung function in IPF patients.

This milestone represents a new era in the treatment of IPF, a rare and debilitating chronic disease that worsens lung function. Namilast tabletshave been shown to slowthe decline in lung function in IPF. Namilast tablets are a welcome new treatment option with a well-tolerated safety profile for physicians to consider for appropriate patients.

The FDA's approval was based on data from two clinical trials: FIBRONER-IFP (NCT05321069) and Trial 2 (NCT04419506). The primary endpoint of FIBRONER-IFP is the absolute change in forced vital capacity (FVC), a measure of lung function, at week 52.2 of 4 milliliters. Compared with placebo, the decrease in FVC of namilast tablets was significantly smaller. Specifically, patients who received 18 mg or namilast tablets had an adjusted mean decrease of -106 ml and -122 ml, respectively, compared with -170 ml in the placebo group. Additionally, the therapeutic effect of namilast 18 mg was demonstrated as early as week 2 compared with the placebo group, with changes in FVC from baseline continuing to differ at week 52.2.

The U.S. Food and Drug Administration's approval of namilast tablets is a critical moment for patients with IPF, as it marks the first time the treatment landscape has changed in more than 10 years. Driven by compelling results from the FIBRONER-IFP trial, this new development underscores the unwavering commitment to changing the way we treat IPF by delivering innovative treatments like namilast.

Most commonly reported in patients treated with nelalast (≥5%), and the adverse reactions that are more common than those in the placebo group are as follows: The 18mg, 9mg and placebo groups of namilast tablets are: diarrhea (42%, 31%, 17%), new coronavirus pneumonia (13%, 16%, 12%), upper respiratory tract infection (13%, 11%, 10%), depression (1 2%, 11%, 10%), weight loss (11%, 10%, 8%), decreased appetite (9%, 9%, 5%), nausea (8%, 9%, 7%), fatigue (7%, 8%, 6%), headache (7%, 6%, 5%), vomiting (6%, 5%, 5%), back pain (6%, 5%, 4%) and dizziness (5%, 6%, 5%). 2

The incidence of discontinuation due to adverse reactions (with or without background antifibrotic therapy) was higher with 18 mg (15%) and 9 mg (12%) compared with placebo (11%). The most common adverse reaction leading to discontinuation of Namilast tablets 18 mg and 9 mg was diarrhea (6% and 2%, respectively).

References:https://www.drugs.com/newdrugs/fda-approves-jascayd-nerandomilast-idiopathic-pulmonary-fibrosis-6634.html