This section highlights FDA-related milestones and regulatory updates for drugs developed by Equillium (EQ).
Over the past two years, Equillium has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EQ101 and itolizumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
EQ101 - FDA Regulatory Timeline and Events
EQ101 is a drug developed by Equillium for the following indication: in adult patients with moderate, severe or very-severe alopecia areata (AA).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EQ101
- Announced Date:
- June 4, 2024
- Indication:
- in adult patients with moderate, severe or very-severe alopecia areata (AA),
Announcement
Equillium Inc announced positive topline data from its Phase 2, single dose, proof-of-concept (PoC) study of EQ101 in adult patients with moderate, severe or very-severe alopecia areata (AA), an autoimmune disease driven by an immune cell attack of the hair follicles that causes hair loss.
AI Summary
Equillium Inc announced positive topline results from its Phase 2, single dose proof-of-concept study of EQ101 in adult patients with moderate, severe, or very-severe alopecia areata. The study focused on evaluating the safety, tolerability, and initial signs of efficacy of EQ101, a novel multi-cytokine inhibitor that blocks IL-2, IL-9, and IL-15, which are involved in the immune cell attack on hair follicles.
Results showed that 20% of all subjects completing the 24-week treatment achieved a Severity of Alopecia Tool (SALT) score of 20 or lower, with 29% of patients with moderate to severe disease reaching that threshold. Importantly, EQ101 was well tolerated with no serious adverse events reported. These promising signs of drug activity support further development and optimization of EQ101 for treating alopecia areata.
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itolizumab - FDA Regulatory Timeline and Events
itolizumab is a drug developed by Equillium for the following indication: Acute graft-versus-host disease (aGVHD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- itolizumab
- Announced Date:
- March 27, 2025
- Indication:
- Acute graft-versus-host disease (aGVHD)
Announcement
Equillium, Inc announced topline data from the Phase 3 EQUATOR study evaluating itolizumab in first-line treatment of patients with acute graft-versus-host disease (aGVHD).
AI Summary
Equillium, Inc. recently announced topline data from its Phase 3 EQUATOR study evaluating itolizumab as a first-line treatment for acute graft-versus-host disease (aGVHD). The study did not show improvements in complete response or overall response rates at Day 29 compared to placebo. However, itolizumab demonstrated statistically significant benefits in longer-term outcomes, including a higher complete response rate at Day 99, extended duration of complete response, and improved failure-free survival. These positive results suggest that, while early responses remain similar to placebo, the drug may offer important long-term benefits for patients with aGVHD—a condition with very high one-year mortality rates and no approved first-line treatments. Based on these findings and prior FDA guidance, Equillium has submitted a request for Breakthrough Therapy designation and an Accelerated Approval meeting, expecting FDA feedback in May 2025.
Read Announcement- Drug:
- itolizumab
- Announced Date:
- February 6, 2025
- Indication:
- Acute graft-versus-host disease (aGVHD)
Announcement
Equillium, Inc announced positive topline results from the Phase 2 study evaluating itolizumab in the treatment of moderate to severe ulcerative colitis (UC).
AI Summary
Equillium, Inc. announced positive topline results from its Phase 2 study on itolizumab for treating moderate to severe ulcerative colitis (UC). In this trial, patients received itolizumab, a fixed 140 mg dose every two weeks over a 12‑week period. The study showed that 23.3% of patients treated with itolizumab achieved clinical remission, compared to 20.0% for those on adalimumab and 10.0% for placebo. Additionally, endoscopic remission rates were 16.7% for both itolizumab and adalimumab, whereas the placebo group had a rate of 6.7%. Researchers noted that itolizumab was generally well tolerated with a safety profile consistent with earlier studies. These promising results support itolizumab as a potential new immune-modulating treatment option for patients with moderate to severe UC, offering an effective alternative to current therapies.
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