Ianalumab
VAY736Strongest active program in the dataset — 8 active P3s across four B-cell-driven autoimmune indications.
Emerging drug — Phase 3 readout — POSITIVE
✓ Won · Read out 2025-08-11Both NEPTUNUS-1 (n=275) and NEPTUNUS-2 (n=504) met primary endpoint — statistically significant ESSDAI improvement vs placebo at week 16, sustained through week 52. First-ever positive Phase 3 for Sjögren's disease. Patient's Global Assessment + Physician's Global Assessment reached nominal significance in NEPTUNUS-1.
Regulatory: First drug ever to show positive Phase 3 in Sjögren's disease; expected NDA / MAA filings.
→ Source PRNext remaining catalyst
AwaitingA positive readout makes TNFRSF13C a validated target for the first time. Hover the badge above for what the confidence level means.
What does it do?
TNFRSF13C — B-cell activating factor receptor (BAFF-R)
Modality: monoclonal antibody (anti-BAFF-R, glycoengineered for ADCC)
Program: VAYHIT (ITP), VAYHIA (AIHA), Sirius (Sjogren's), Daylight (lupus)
The 8 Phase 3 trials
| NCT ID | Indication | N | Status | Started | Primary completion | Readout |
|---|---|---|---|---|---|---|
| NCT05648968 | Warm Autoimmune Hemolytic Anemia (wAIHA) | 90 | ACTIVE_NOT_RECRUITING | 2022-12-30 | 2026-02-20 (actual) | Awaiting |
| NCT05653219 | Primary Immune Thrombocytopenia | 152 | ACTIVE_NOT_RECRUITING | 2023-02-02 | 2025-06-19 (actual) | Awaiting |
| NCT05653349 | Primary Immune Thrombocytopenia (ITP) | 226 | ACTIVE_NOT_RECRUITING | 2023-02-03 | 2026-10-29 | Fresh est. |
| NCT05639114 | Systemic Lupus Erythematosus | 436 | ACTIVE_NOT_RECRUITING | 2023-03-02 | 2027-03-24 | Fresh est. |
| NCT05624749 | Systemic Lupus Erythematosus | 288 | ACTIVE_NOT_RECRUITING | 2023-04-21 | 2027-04-12 | Fresh est. |
| NCT05985915 | Sjogrens Syndrome | 612 | ACTIVE_NOT_RECRUITING | 2023-10-27 | 2033-04-22 | Stale est. |
| NCT06133972 | Systemic Lupus Erythematosus | 550 | RECRUITING | 2024-05-21 | 2030-04-08 | Fresh est. |
| NCT06711887 | Lupus Nephritis | 315 | RECRUITING | 2025-05-19 | 2030-07-16 | Fresh est. |
What's the case for and against?
✓ What's working in its favor
- Phase 2 Sjogren's data published Lancet 2018 with significant ESSDAI improvement
- First B-cell depleting therapy specifically targeting BAFF-R (vs. CD20)
Who else is racing? — 2 other assets at TNFRSF13C
| Asset | Sponsor | Status |
|---|---|---|
| Belimumab | GSK | Approved (anti-soluble BAFF/BLyS — different target) · Different mechanism — anti-ligand vs anti-receptor |
| Iscalimab | Novartis | P2 — anti-CD40 not anti-BAFF-R |
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.