Asset profile

Frexalimab

Monoclonal antibody

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Phase 3underway

Evidence outlook · registrational

Multiple Sclerosis: registrational readout pending

Its supporting mid-stage evidence has not yet been graded on this platform. Registrational readout expected around 2027-05-06.

Also in development:Systemic Lupus Erythematosus · Phase 2

How the evidence outlook works ↗

Competitive landscape

95 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 95 same-indication; 33 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Frexalimab: this drugPhase 3Monoclonal antibodyCD40 ligand (CD40L / CD154)
Aldesleukin (Proleukin)ApprovedRecombinant Cytokine (il-2)Interleukin-2 receptor (IL-2R)
AlemtuzumabApprovedMonoclonal antibodyCD52
AnifrolumabApprovedMonoclonal antibodyType I interferon receptor, Type I interferon receptor subunit 1 (IFNAR1)
Avacopan (Tavneos)ApprovedSmall moleculeComplement C5a receptor 1 (C5aR1/CD88)
BafiertamApprovedSmall moleculeNrf2 pathway (fumaric acid ester)
Belimumab (GSK1550188)ApprovedMonoclonal antibodyBAFF / BLyS (B-lymphocyte stimulator), BAFF (BLyS)
Cladribine (MAVENCLAD®)ApprovedSmall moleculeAdenosine deaminase-resistant purine analog, DNA synthesis machinery in lymphocytes
CopaxoneApprovedPeptideMyelin basic protein-mimetic immunomodulation
Deucravacitinib (Sotyktu)ApprovedSmall moleculeTYK2
Dimethyl Fumarate (Tecfidera)ApprovedSmall moleculeNrf2 pathway (fumaric acid ester)
Diroximel Fumarate (Vumerity)ApprovedSmall moleculeNrf2 pathway (fumaric acid ester)
DRFApprovedSmall moleculeNrf2 pathway (fumaric acid ester)
Fampridine (Ampyra / Fampyra)ApprovedSmall moleculePotassium Channel Blocker, Voltage-gated potassium channel (Kv), Voltage-gated potassium channels (Kv1/Shaker/KCNA family)
Fingolimod (Gilenya)ApprovedSmall moleculeSphingosine 1-phosphate receptor (S1PR, specifically S1P1), S1P receptor, Sphingosine-1-phosphate receptors (S1P1, S1P3, S1P4, S1P5)
Interferon Beta-1a (Avonex)ApprovedBiologic (subtype unspecified)Type I Interferon receptor (IFNAR)

…and 80 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(6 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
December 2026 (1)
Phase 2Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal LesionRecruiting
Est. primary completion 2026-12-23 · NCT06500702 · CT.gov ↗
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2027 (3)
April 2027 (1)
Phase 2Type 1 Diabetes MellitusActive not recruiting
Est. primary completion 2027-04-28 · NCT06111586 · CT.gov ↗
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May 2027 (1)
Phase 3Multiple SclerosisActive not recruiting
Est. primary completion 2027-05-06 · NCT06141473 · CT.gov ↗
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July 2027 (1)
Phase 3Multiple SclerosisRecruiting
Est. primary completion 2027-07-15 · NCT07325292 · CT.gov ↗
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2028 (1)
March 2028 (1)
Phase 3Multiple SclerosisActive not recruiting
Est. primary completion 2028-03-24 · NCT06141486 · CT.gov ↗
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2029 (1)
August 2029 (1)
Phase 2/3Kidney Transplant RejectionRecruiting
Est. primary completion 2029-08-15 · NCT07412470 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (3)
Phase 2/3 (1)
Phase 2 (3)
Appears in other studies (1)