Clinical trialsCompany release

Novartis reports 52-week Phase III data for Rhapsido in chronic inducible urticaria

Novartis Pharma AG · Thu 12 Nov 2026

Novartis says remibrutinib 25 mg twice daily showed early, sustained efficacy to Week 52 in three chronic inducible urticaria subtypes, with results due at ACAAI 2026.

Novartis announced on 12 November 2026 the 52-week results of RemIND, a Phase III study of Rhapsido (remibrutinib) in chronic inducible urticaria (CIndU). The dose studied was 25 mg taken twice daily.

According to the company, efficacy was seen early and was maintained through Week 52. The effect was reported in three subtypes of the condition: symptomatic dermographism, cold urticaria and cholinergic urticaria.

Novartis said the data will be presented as a late-breaking abstract at the ACAAI 2026 Annual Scientific Meeting. The material available to VigiEye did not include detailed endpoint figures, safety findings or any information on regulatory filings in CIndU, so those points cannot be assessed yet.

Late-breaking abstracts are typically released close to the time of presentation, so fuller efficacy and safety detail may only emerge at the meeting itself.

What it means for your team

  • Regulatory teams should note that the announcement covers three CIndU subtypes, but no filing plans or label-expansion timelines were given in the information available.
  • Pharmacovigilance and safety teams should wait for the full 52-week safety data before drawing conclusions on long-term tolerability.
  • Market-access teams can start tracking the programme, but a value assessment needs the detailed endpoint data to be presented at ACAAI.

Company's press release: Novartis Pharma AG ↗

Article written by VigiEye from the official source (Novartis Pharma AG). Claims are the company's own. AI-assisted; check the source before acting.

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