Amlitelimab
Development of Amlitelimab for alopecia areata was discontinued by Sanofi.
Sanofi's OX40L antibody, tested in severe alopecia areata as an alternative to blocking JAK; the trial was terminated in 2026 and the drug dropped from atopic dermatitis the same summer.
This programme is no longer being actively pursued.
- Developed by
- Sanofi
- Current phase
- Discontinued
- Mechanism
- Immunomodulator
- Indications
- Alopecia areata
- Also known as
- SAR445229, KY1005
- Last public activity
- August 2026
- Copy last reviewed
- September 2026
- Record confidence
- High
Development stopped.
Retunes the immune system more broadly than a single pathway.
A research record, not medical advice: being listed here says nothing about whether a treatment works or whether it is right for you. Talk to a dermatologist about your own case.
How it is meant to work
A fully human, non-depleting monoclonal antibody against OX40L, given by subcutaneous injection. It interrupts the T-cell costimulation that drives the autoimmune attack rather than inhibiting the JAK signalling downstream of it — a different point on the same pathway.
Why it matters
Alopecia areata has approved JAK inhibitors in the US, EU and Japan, so the question had moved on to what you give the people they do not work for, and whether a target further upstream can be safer. Amlitelimab was the largest such bet: a 166-patient placebo-controlled Phase 2 proof-of-concept in severe disease, terminated by Sanofi in 2026 by sponsor decision unrelated to safety, with no result released. In July 2026 Sanofi also decided not to file amlitelimab in atopic dermatitis, its lead indication, saying the evidence did not support further development there, and trade press reports alopecia areata among the indications no longer in its pipeline. Listed as discontinued on that basis.
Development history
- Phase 2
First Phase 2 trial on record: NCT06444451 — A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
ClinicalTrials.gov ↗
Registered trials
Pulled automatically from ClinicalTrials.gov. Matching is by name and development code, so occasional gaps are possible — tell us if you spot one.
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
Sanofi · n=166 · June 2024
Listing a trial is not a recommendation to join one. Eligibility, risks and costs vary enormously — discuss any trial with your own doctor first.
Sources
- Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adults With Severe Alopecia Areata — ClinicalTrials.gov
- Sanofi press release of 24 July 2026: decision not to submit amlitelimab in atopic dermatitis — Company release, July 2026
- Sanofi's $1.4B Kymab bet falters again as atopic dermatitis trials scrapped (alopecia areata no longer listed) — Press, July 2026
Related programmes
Other programmes in the register with the same mechanism: Immunomodulator.
Cite this page
Hair Pipeline, "Amlitelimab — development record", hairpipeline.com/pipeline/amlitelimab