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Drug

Sipavibart

Approved · EMA
Early-to-mid development
RxNorm2703545UNII977D2P9YYW
1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Sipavibart
RxNorm CUI
2703545
UNII
977D2P9YYW
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2025-01-20
Latest approval
2025-01-20
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2025-01-20Approval
Approval: Kavigale (EMA)
Indication: Kavigale is indicated for the pre-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older weighing at least 40 kg and who are immunocompromised due toShow full indication

Kavigale is indicated for the pre-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older weighing at least 40 kg and who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments.Kavigale should be used in accordance with official recommendations where available and based on information on the activity of sipavibart against presently circulating viral variants (see sections 4.4 and 5.1).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

1 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
1
registered trials across all phases
1
Active studies
1
Recruiting
PHASE DISTRIBUTIONn = 1
Phase 21
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.