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Drug

Lonoctocog alfa

Approved medicine
ClassCoagulation factor VIII exogenous proteinResearchOngoing clinical research

Also known as Afstyla, antihemophilic fact(VIII) rec.sing-chn B-dom trunc, rVIII-SingleChain.

RxNorm1796377ChEMBLCHEMBL4594603UNIIVQ723R7O8R
Coagulation factor VIII
Primary target
1
Regulatory events
Latest activity
beta

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

A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects With Severe Hemophilia A

Clinical trial2021-10-27Results posted · ClinicalTrials.gov

A Phase III Open-label Pharmacokinetic, Efficacy and Safety Study of rVIII-SingleChain in a Pediatric Population With Severe Hemophilia A

Clinical trial2017-01-27Results posted · ClinicalTrials.gov

Approval: Afstyla (EMA)

Regulatory2017-01-04EMA

A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Human Antihaemophilic Factor VIII (rFVIII; INN: Octocog Alfa) in Subjects With Hemophilia A, and a Repeat PK, Safety and Efficacy Study

Clinical trial2016-08-09Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name
Lonoctocog alfa
Aliases & brands
Afstylaantihemophilic fact(VIII) rec.sing-chn B-dom truncrVIII-SingleChain
RxNorm CUI
1796377
ChEMBL ID
CHEMBL4594603
UNII
VQ723R7O8R
Primary mechanism
Coagulation factor VIII exogenous protein
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Coagulation factor VIII
F8 · P00451
EXOGENOUS PROTEINCoagulation factor VIII exogenous protein

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
2017-01-04
Latest approval
2017-01-04
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2017-01-04Approval
Approval: Afstyla (EMA)

Indication: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Afstyla can be used for all age groups.

Evidence ↗

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

Clinical trials

3 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
3
registered trials across all phases
LATEST COMPLETION 2021
3
Late-stage (III+)
3
Completed
PHASE DISTRIBUTIONn = 3
Phase 2 / 31Phase 32

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects With Severe Hemophilia A

CompletedPH IIICSL Behringn=2462021

A Phase III Open-label Pharmacokinetic, Efficacy and Safety Study of rVIII-SingleChain in a Pediatric Population With Severe Hemophilia A

CompletedPH IIICSL Behringn=842015

A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Human Antihaemophilic Factor VIII (rFVIII; INN: Octocog Alfa) in Subjects With Hemophilia A, and a Repeat PK, Safety and Efficacy Study

CompletedPH II/IIICSL Behringn=1752014

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects With Severe Hemophilia A

CompletedPH IIICSL Behringn=2462021

A Phase III Open-label Pharmacokinetic, Efficacy and Safety Study of rVIII-SingleChain in a Pediatric Population With Severe Hemophilia A

CompletedPH IIICSL Behringn=842015

A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Human Antihaemophilic Factor VIII (rFVIII; INN: Octocog Alfa) in Subjects With Hemophilia A, and a Repeat PK, Safety and Efficacy Study

CompletedPH II/IIICSL Behringn=1752014
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.