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API (Commercialized)GMP/DMFRespiratory / COPD

Ensifentrine

Maintenance treatment of chronic obstructive pulmonary disease (COPD)

CAS No.
298680-25-8
Indication Class
Respiratory
Patent Expiry
To be assessed
Therapeutic Area
Respiratory / COPD
Target / Mechanism
PDE3A·PDE3B·PDE4A·PDE4D·PDE4B·+more
Labeled Purity
99%+
Registration Readiness
GMP/DMF
Commercialization Tier
API (Commercialized)
Linked Intermediates
6 key intermediates available
PDE3/4 Dual InhibitorInhaled DeliveryNovel Mechanism

Key Intermediates for This API

Order: listed intermediates that accept enquiries first; fragments shared across several APIs rank higher

Listing Logic · Why It's Worth Listing

The first novel-mechanism inhaled COPD maintenance therapy in over a decade, combining bronchodilation and anti-inflammation, filling the gap after triple therapy.

Demand

Respiratory / COPD · Marketed; available for immediate sourcing

Compliance

GMP/DMF-ready; supports regulatory filing and audit in target markets

Supply

6 key intermediates available; scale-up and cost control manageable

Product Description

Ensifentrine is a groundbreaking, first-in-class treatment for COPD. Uniquely targeting both the PDE3 and PDE4 pathways, it works by simultaneously opening airways (bronchodilation) and reducing lung inflammation with a single inhaled medicine. Approved by the FDA in June 2024, it is delivered directly to the lungs for targeted relief in adults with chronic obstructive pulmonary disease.

Supply source: Unibest · Ensifentrine, sourced, vetted and delivered by Unibest. Therapeutic area, indication and listing rationale are qualitative summaries based on public drug knowledge for business reference; actual registration availability and quality specifications are subject to DMF/GMP documentation and the technical agreement confirmed at order.