Frexalimab
SAR441344Engineered second-gen anti-CD40L that avoids the thromboembolic events that killed first-gen drugs (ruplizumab) 20 years ago. P3 in MS with two arms (n=1,600 + n=900) plus T1D and FSGS Phase 2.
When will we know if it works?
Fresh est.A positive readout makes CD40LG a validated target for the first time. Hover the badge above for what the confidence level means.
What does it do?
CD40LG — CD40 ligand (CD154)
Modality: monoclonal antibody (anti-CD40L, Fc-engineered to avoid platelet activation)
Program: FREXALT (MS), FREXTON (T1D)
The 4 Phase 3 trials
| NCT ID | Indication | N | Status | Started | Primary completion | Readout |
|---|---|---|---|---|---|---|
| NCT06141473 | Multiple Sclerosis | 1,600 | RECRUITING | 2023-12-13 | 2027-05-06 | Fresh est. |
| NCT06141486 | Multiple Sclerosis | 900 | RECRUITING | 2023-12-27 | 2026-12-23 | Fresh est. |
| NCT07325292 | Multiple Sclerosis | 160 | RECRUITING | 2026-01-14 | 2027-07-15 | Fresh est. |
| NCT07412470 | Kidney Transplant Rejection | 526 | RECRUITING | 2026-03-13 | 2029-08-15 | Fresh est. |
What deals have been done?
| Year | Type | Counterparty | Value |
|---|---|---|---|
| 2017 | license | ImmuNext | License (undisclosed) |
What's the case for and against?
✓ What's working in its favor
- Phase 2 RMS: significant reduction in new T1 Gd+ MRI lesions vs placebo
- Largest P3 enrollment in CD40L space (n=1,600)
⚠ What's the biggest risk
- First-generation anti-CD40L (e.g., ruplizumab/IDEC-131) caused thromboembolism in P2 trials around 2002 — entire class shelved for two decades
Who else is racing? — 4 other assets at CD40LG
| Asset | Sponsor | Status |
|---|---|---|
| Dapirolizumab pegol | UCB Biopharma | P3 SLE |
| Dazodalibep | Amgen (via Horizon) | P3 Sjogren's |
| Tegoprubart (AT-1501) | Eledon Pharmaceuticals | P2 kidney transplant rejection |
| TNX-1500 | Tonix Pharmaceuticals | P1 healthy volunteers / P2 transplant |
Source: TheraRadar atomic trial table (built 2026-04-28 from ClinicalTrials.gov v2 API). Trial-target mapping validated via Gemini 2.0 + Gemini 3.1 Lite + Claude Haiku 4.5 multi-LLM consensus, with Claude Sonnet 4.6 arbitration. BD context curated by hand from public disclosures.