What's the most recent regulatory action in Systemic sclerosis associated interstitial lung disease?

Most recent: Ofev — FDA approved.

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Last reviewed 2026-06-10 · How we verify

Systemic sclerosis associated interstitial lung disease — Treatment Landscape & Competitive Intelligence

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Systemic sclerosis associated interstitial lung disease (disease) competitive landscape: 3 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

3 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Systemic sclerosis associated interstitial lung disease, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	Target	First approval
Ofev	NINTEDANIB	Boehringer Ingelheim	Kinase Inhibitor	Receptor-type tyrosine-protein kinase FLT3	2014-01-01
OFEV®	OFEV®	Boehringer Ingelheim	Kinase Inhibitor	Calcium/calmodulin-dependent protein kinase type IV, Cyclin-dependent kinase 18, Cyclin-dependent kinase-like 2
vargatef	vargatef	ARCAGY/ GINECO GROUP		Calcium/calmodulin-dependent protein kinase type IV, Cyclin-dependent kinase 18, Cyclin-dependent kinase-like 2

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

2026-04-02 — Ofev · FDA · approved · US
2026-04-02 — Ofev · FDA · approved · US
2026-04-02 — Ofev · FDA · approved · US
2026-04-02 — Ofev · FDA · approved · US
2026-04-02 — Ofev · MOH · likely_approved · IL
2026-04-02 — Ofev · HSA · likely_approved · SG
2026-04-02 — Ofev · SFDA · likely_approved · SA
2026-04-02 — Ofev · MOH · likely_approved · AE
2026-04-02 — Ofev · MFDS · likely_approved · KR

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

Boehringer Ingelheim · 2 drugs in Systemic sclerosis associated interstitial lung disease
ARCAGY/ GINECO GROUP · 1 drug in Systemic sclerosis associated interstitial lung disease

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Every new regulatory action, PDUFA date, or trial completion in Systemic sclerosis associated interstitial lung disease:

Cite this brief

Drug Landscape (2026). Systemic sclerosis associated interstitial lung disease — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/systemic-sclerosis-associated-interstitial-lung-disease. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing