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Drug

Carfilzomib

Established medicine
Class26S proteasome inhibitorResearchOngoing clinical research

Also known as Kyprolis, karfilzomib.

72
Active clinical trials
38
Protein targets
4
Regulatory events
Latest activity
beta

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

A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study

Clinical trial2026-07-31Status changed to Active, not recruiting · ClinicalTrials.gov

Approval: CARFILZOMIB (ANDA209526)

Regulatory2026-07-20FDA

Profile

Identifiers & mechanism

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

Canonical name
Carfilzomib
Aliases & brands
Kyproliskarfilzomib
RxNorm CUI
1302966
ChEMBL ID
CHEMBL451887
ATC codes
L01XG02
UNII
72X6E3J5AR
Primary mechanism
26S proteasome inhibitor
Regulatory jurisdictions
emamhrafda

Pharmacology & targets

38 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor
INHIBITOR26S proteasome inhibitor

Regulatory timeline

4 events

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
2015-11-19
Latest approval
2026-07-20
Authorities
FDA · EMA · MHRA
Total events
4
fdaU.S. Food and Drug Administration· 1 event
2026-07-20Approval
Approval: CARFILZOMIB (ANDA209526)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2015-11-19Accelerated approval
Accelerated approval: Kyprolis (EMA)
Indication: Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients withShow full indication

Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2019-11-21Safety communicationSafety
Drug Safety Update: Carfilzomib (Kyprolis▼): risk of reactivation of hepatitis B virus
Evidence ↗
2019-08-19Safety communicationSafety
Drug Safety Update: Carfilzomib (Kyprolis▼): reminder of risk of potentially fatal cardiac events
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

198 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
198
registered trials across all phases
LATEST COMPLETION 2026
72
Active studies
28
Recruiting
30
Late-stage (III+)
86
Completed
40
Discontinued
PHASE DISTRIBUTIONn = 198
Early Phase 11Phase 148Phase 1 / 243Phase 276Phase 327Phase 42Phase N / A1

Late-stage studies

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

Recent completions

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

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.