Boehringer Ingelheim’s Jascayd (nerandomalist) has got the US Food and Drug Administration (FDA) nod in idiopathic pulmonary fibrosis (IPF), making it the first drug to be approved in this indication in more than a decade.

The preferential phosphodiesterase 4B (PDE4B) inhibitor is a first in its class that acts by exerting immunomodulatory and antifibrotic effects. These contribute to the slowing of lung function decline in patients.

The drug obtained the FDA go-ahead after two positive Phase III readouts, including the FIBRONEER-ILD (NCT05321082) and FIBRONEER-IPF (NCT05321069) studies. During these trials, Jascayd was found to boost lung function by slowing forced vital capacity (FVC) decline.

Following its market debut, Scott Staszak, president and CEO of the Pulmonary Fibrosis Foundation, noted that Jascayd could fulfil the “long-standing need for new treatment options in IPF”.

According to Staszak, the drug will also provide an important addition to IPF’s treatment landscape, which has lain dormant since the approval of anti-fibrotics pirfenidone and Boehringer’s Ofev (nintedanib), for which generics are now marketed.

Jascayd could set a new standard in IPF

Since the respective approvals of pirfenidone and nintedanib in IPF, these two drugs have been the standard of care (SoC) for patients, though they are commonly associated with strong side effects. This includes severe liver damage, meaning patients with compromised liver function may not be able to take this combination.

According to analysts in GlobalData’s Immunology team, Jascayd approval will be a positive development for patients. “Jascayd is a new, effective treatment with a similar side effect profile to placebo,” which they note will be a welcome advance for those unable to tolerate currently approved therapies.

Over time, analysts forecast that the drug will obtain patient share from pirfenidone-nintedanib, allowing the drug to “further penetrate the IPF market”.

They also predict the drug’s clinical uptake to be swift, citing its “strong clinical backing and favourable safety profile,” as well as the “flexibility to use Jascayd alone or alongside existing treatment.”

IPF market set for future growth

Though the IPF market had not seen new blood since 2014, the indication’s dynamic appears to be shifting, as a big pharma and biotech push has seen a range of hopefuls reach late-stage trials.

This includes Bristol Myers Squibb’s (BMS) admilparant, which is in a Phase III trial for IPF.

In September 2025, United Therapeutics’ Tyvaso (inhaled treprostinil) showed benefit in the Phase III TETON-2 study (NCT05255991), with a significant 95.6mL increase in FVC from baseline. This data will tee the company up to apply for approval of the therapy in the US once it receives data from the TETON-1 trial (NCT04708782).

EmphyCorp’s antioxidant, sodium pyruvate, is also in the registrational phase for IPF.