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# Equillium Gets Fast Track for Itolizumab
- URL: https://www.fdaweb.com/equillium-gets-fast-track-for-itolizumab/
- Published: 2019-12-09T12:00:00.000Z
- Updated: 2026-09-14T15:55:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145683

FDA has granted Equillium a fast track designation for itolizumab for treating lupus nephritis. In September, Equillium initiated the [EQUALISE Phase 1b study](https://www.globenewswire.com/Tracker?data=DKepA6fkNGFpKI9C1jnchooOh8b9Fzaqd1qIX20yoSxg0N%5FB7nxd9TJzmrmbaEOopPgeKjQwBgiz0qgZRNTzDnru1zCqExhBMH3l8pDDOyZL%5FBLVkc55jVJl%5FH3Ku-loCf-PrXQXfd6inqs8SV5WOg==&ref=fdaweb.com) of itolizumab in patients with lupus and lupus nephritis. The study will have two cohorts: Type A is an open-label cohort and will treat patients with systemic lupus erythematosus for four weeks; Type B is a double-blind, placebo-controlled cohort and will treat patients with active proliferative lupus nephritis for 12 weeks, according to the company.

Itolizumab is described as a clinical-stage, first-in-class monoclonal antibody that selectively targets the novel immune checkpoint receptor CD6\. “CD6 plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases,” it says. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.