Ayutara ...
PALI-2108

PALI-2108

Once‑daily oral program advancing toward Phase 2 for UC and FSCD.

A selective JAK1/TYK2 inhibitor with gut-restricted exposure, designed for superior efficacy and safety in inflammatory bowel disease.

Target Indications

Ulcerative Colitis (UC)

Moderate-to-severe UC patients unresponsive to conventional therapy. Aiming for mucosal healing and steroid-free remission.

Fistulizing Crohn’s Disease (FSCD)

Perianal and enterocutaneous fistulas. Targeting fistula closure and sustained clinical response.

Development Roadmap

Q4 2024
IND Filing

DCGI & FDA submission completed.

Q1 2025
Phase 1 SAD/MAD

First-in-human safety & PK in 48 volunteers.

Q3 2025
Phase 1b in UC

Proof-of-concept in 30 patients.

Q1 2026
Phase 2 Start

Global multi-center trial initiation.

Safety Advantage

75%
Gut-Restricted
  • Minimal systemic exposure – < 5% bioavailability
  • No hematologic signals in preclinical models
  • No CV risk markers observed in Phase 1
  • Well-tolerated up to 800mg QD
PALI-2108 Granted Fast Track by DCGI Phase 1 Topline Data at ECCO 2025 $45M Series B Led by Matrix Partners India Partnership with AIIMS Delhi for Phase 2 PALI-2108 Granted Fast Track by DCGI