Drug Profile

SPY 003

Alternative Names: PR-014; SPY 003 207; SPY-003

Latest Information Update: 25 Sep 2025

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At a glance

Originator Paragon Therapeutics
Developer Altasciences; Spyre Therapeutics
Class Anti-inflammatories; Monoclonal antibodies
Mechanism of Action Interleukin-23 subunit p19 inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes

Highest Development Phases

Phase II Ulcerative colitis
Phase I Inflammatory bowel diseases

Most Recent Events

27 May 2025 Phase-II clinical trials in Ulcerative colitis (Monotherapy) in Ukraine, Moldova, USA and Serbia (IV) (NCT07012395)
27 May 2025 Phase-II clinical trials in Ulcerative colitis (Monotherapy) in Ukraine, Moldova, USA and Serbia (SC) (NCT07012395)
08 May 2025 Spyre Therapeutics plans a phase I trial (SC) by February 2026

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