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  1. pharmadog
  2. ›drugs
  3. ›Voyxact
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sibeprenlimab

Marketedupdated 3mo ago
by Visterra Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • tagApproval4 co-mentions · 1 sources
  • drugVOYXACT4 co-mentions · 1 sources

all catalysts(1)

approval · 1
Nov 25, 2025
approval
9mo ago
VOYXACT (SIBEPRENLIMAB-SZSI) — FDA approval
sibeprenlimab
→

Trials studying sibeprenlimab

  • phase3Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)active not recruitingn=530
  • phase2A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren'sactive not recruitingn=83
  • phase1Safety and Tolerability, and PK of Sibeprenlimab in Chinese Healthy Subjectcompletedn=24
  • phase2Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissuerecruitingn=25
  • phase3Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathyenrolling by invitationn=600

News(10)

  • Vera’s newly approved IgA nephropathy drug supports kidney function, like Otsuka’s Voyxact
    Otsuka Pharmaceuticals’ Voyxact is not the only IgA nephropathy drug that can slow the decline of kidney function. Vera Therapeutics’ Trutakna, which the FDA granted accelerated approval last month…
    biospace · 18h ago
  • Boulevard starts up with $65M to pursue targeted autoimmune drugs
    Co-founded by pioneering researcher Georg Schett and ex-Sanofi CSO Frank Nestle, the startup is advancing a trio of multifaceted antibodies with the potential to treat several immune diseases.
    biopharma_dive · 5d ago
  • Otsuka succeeds with kidney drug; BioNTech downgrades revenue projection
    ✅ Otsuka’s confirmatory kidney disease data: The drugmaker said Voyxact met a key secondary endpoint in the Phase 3 VISIONARY study in patients with IgA nephropathy (IgAN). The treatment increased…
    endpoints · 13d ago
  • Vertex unfazed by competitive IgAN space as FDA verdict looms
    Positive two-year follow-up data for Otsuka Pharmaceuticals’ IgA nephropathy drug Voyxact could support the FDA’s ongoing review of Vertex Pharmaceuticals’ povetacicept, CEO Reshma Kewalramani said…
    biospace · 13d ago
  • Vera Therapeutics wins FDA nod for closely watched kidney disease drug
    The clearance marks another step forward in treatment for IgA nephropathy and sets up a commercial battle with Otsuka, which brought a similar medication to market last year.
    biopharma_dive · 1mo ago
  • Otsuka reports long-term kidney data key to Voyxact's bid for full approval
    Otsuka on Thursday reported new long-term data that it hopes will convert an accelerated approval to a full green light in kidney disease. The company said the Phase 3 study showed Voyxact stabiliz…
    endpoints · 1mo ago
  • BridgeBio gets funding for drug launch; United buys into cell therapy
    Elsewhere, Otsuka’s kidney drug hit the goal of a confirmatory trial and Vertex’s CRISPR sickle cell drug secured expanded approval.
    biopharma_dive · 1mo ago
  • Otsuka touts new IgAN evidence as it seeks full approval for Voyxact
    Otsuka Pharmaceutical reported new evidence on Thursday that it thinks will help support a full approval for its monoclonal antibody Voyxact in a chronic autoimmune disease that affects the kidneys…
    endpoints · 2mo ago
  • STAT+: Otsuka kidney drug slowed loss of function, but less than expected, in late-stage trial
    Otsuka’s Voyxact slowed the loss of kidney function after one year in patients with a chronic autoimmune kidney disease, but the benefit was less than expected.
    stat · 2mo ago
  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    biopharma_dive · 2mo ago
view all news mentions →
brand
Voyxact
generic
sibeprenlimab-szsi
indication
Sicca Syndrome (Sjogren)
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 13m ago
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