Drug Profile

iTOL 102

Alternative Names: iTOL-102

Latest Information Update: 12 Nov 2025

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At a glance

Originator iTolerance
Developer iTolerance; NewcelX
Class Stem cell therapies
Mechanism of Action Pancreatic beta cell replacements

Orphan Drug Status

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

No
New Molecular Entity No

Highest Development Phases

Preclinical Type 1 diabetes mellitus

Most Recent Events

04 Nov 2025 NewcelX plans a phase I trial for Type 1 diabetes mellitus in the US
30 Oct 2025 Kadimastem has merged with NLS Pharmaceutics Ltd to form NewcelX
18 Jul 2025 iTolerance and Kadimastem completes Type-B pre-IND meeting with the US FDA for iTOL 102 for the treatment of type 1 diabetes mellitus

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