drug · small molecule
nerandomilast
Marketedupdated 3mo agoby Boehringer Ingelheim International GmbH🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 4Small molecule drug with a maximum clinical stage of Phase 3 (across all indications), with 5 investigational indications.
indications
investigational
Pulmonary Fibrosis
all catalysts(3)
Trials studying nerandomilast
- phase3A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
- phase3A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
- phase3A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
- phase3A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)
- phase3FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
- phase3A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
- phase2Platform Clinical Study for Conquering Scleroderma
- phase1A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food
Patent cliff
source: FDA Orange Bookfirst barrier falls
Dec 19, 2028
~2.3 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (10)
- Oct 22, 2038method-of-use (U-4297)US 11406638
- Oct 22, 2038method-of-use (U-4297)US 11406638
- Oct 22, 2038method-of-use (U-4292)US 11813266
- Oct 22, 2038method-of-use (U-4292)US 11813266
- Feb 19, 2034method-of-use (U-4298)US 9802954
- Feb 19, 2034method-of-use (U-4298)US 9802954
- Aug 23, 2032compositionUS 8609670
- Aug 23, 2032compositionUS 8609670
- Nov 26, 2029compositionUS 87540733.3y
- Nov 26, 2029compositionUS 87540733.3y
FDA exclusivities (4)
- Oct 7, 2030NCENew Chemical Entity (5y)4.1y
- Oct 7, 2030NCENew Chemical Entity (5y)4.1y
- Dec 19, 2028I-979Indication (3y)2.3y
- Dec 19, 2028I-979Indication (3y)2.3y
News(3)
- How well are AI-discovered drugs faring in the clinic?Some of the industry’s most closely-watched AI drugs could provide insight into the success of technology-assisted development.biopharma_dive · 1mo ago
- A PureTech startup banks $180M for a new IPF drugCelea, backed by investors such as RA Capital and Leaps by Bayer, is making what it says is an improved version of Roche's Esbriet.biopharma_dive · 1mo ago
- Avalyn, in pursuit of better lung drugs, banks $300M in an IPOThe biotech will use the proceeds to develop inhalable versions of therapies already on the market for the “idiopathic” and “progressive” forms of pulmonary fibrosis.biopharma_dive · 3mo ago
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