From the first approved antifibrotic therapies to the latest IPF breakthroughs
Ten years after the landmark approvals that reshaped IPF treatment, the field stands on the brink of another wave of innovation. With new therapies advancing through the clinic, fresh biological insights emerging, and investment returning to pulmonary fibrosis, there has never been a more exciting time to be part of the IPF community. Before looking ahead to the next chapter of IPF drug development, let's take a moment to recap the major milestones that have shaped the field over the past two decades.
Pulmonary Fibrosis - The Past Decade in a Nutshell
2014
Nintedanib was approved by the FDA for the treatment of idiopathic pulmonary fibrosis on October 15, 2014.
2014, Late October 2014
Pirfenidone was approved by the FDA
2021
February, 2021 Galapagos and Gilead announced announce discontinuation of the ISABELA Phase 3 Study for ziritaxestat due benefit-risk profile no longer supported
2022
January, 2022, Genentech/Roche’s primary patent for Esbriet®(pirfenidone) expires
2022, May
May, 2022 Sandoz launches first generic pirfenidone in US for patients with idiopathic pulmonary fibrosis
2023, June
June, 2023 FibroGen announce pamrevlumab failed to meet primary endpoint in Phase 3 Study in IPF and discontinuation of study
2023, August
August, 2023 Galecto announce GALACTIC-1 Phase 2b trial of inhaled GB0139 did not meet its primary endpoint and discontinuation of study
2023, August
August 2023 Lupin Limited gains FDA approval for to market a generic equivalent of Esbriet® Tablets
2024
⭐ September, 2024 Boehringer Ingelheim announces FIBRONEER™-IPF Phase 3 Study for nerandomilast meets its primary endpoint in the largest trial in idiopathic pulmonary fibrosis conducted to date
2025, March
March, 2025 Pliant Therapeutics announces
discontinuation of BEACON-IPF 2b/3 trial for bexotegrast in IPF due to adverse events in the treatment arms compared to placebo.
2025, December
December 2025, Approval of Boehringer Ingelheim’s nerandomilast for Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
2026, March
March 2026, United Therapeutics announces TETON-1 Phase 3 Study for Tyvaso meets its primary endpoint in idiopathic pulmonary fibrosis
2026, April
April, 2026 Boehringer Ingelheim’s Ofev (nintendanib) primary composition of matter patent expires in US
2026, October
October, 2026 Bristol Myers Squibb’s ALOFT Phase 3 Study for admilparant (BMS-986278) set to read out
The Future?
The future of IPF is still being written. While it's impossible to predict what's next, the progress made over the past decade gives plenty of reason for optimism. Join us at the 10th IPF Summit to meet the experts driving innovation from discovery through to clinical development.
I would recommend this excellent IPF summit to anyone interested to learn fast or get updates from the best IPF experts! I always rely on this conference to get up to date and discuss the most relevant IPF science and drug development!
Medical Director, Respiratory, Novartis AG