Skip to content
Empaveli, Aspaveli(pegcetacoplan)
Aspaveli, Empaveli, Syfovre (pegcetacoplan) is a protein pharmaceutical. Pegcetacoplan was first approved as Empaveli on 2021-05-14. It has been approved in Europe to treat paroxysmal hemoglobinuria.
Download report
Favorite
FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
Trade Name
FDA
EMA
Empaveli, Syfovre
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pegcetacoplan
Tradename
Company
Number
Date
Products
EMPAVELIApellis PharmaceuticalsN-215014 RX2021-05-14
1 products, RLD, RS
SYFOVREApellis PharmaceuticalsN-217171 RX2023-02-17
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
empaveliNew Drug Application2021-08-10
syfovreNew Drug Application2023-03-01
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
PEGCETACOPLAN, EMPAVELI, APELLIS PHARMS
2028-05-14ODE-351
2026-05-14NCE
2026-02-08M-288
PEGCETACOPLAN, SYFOVRE, APELLIS PHARMS
2026-05-14NCE
2026-02-22NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Pegcetacoplan, Empaveli, Apellis Pharms
110401072038-04-09DPU-3172, U-3173, U-3174
100358222033-11-15DP
108758932033-11-15DPU-3124, U-3540
112928152033-11-15DS, DPU-3124, U-3354, U-3540
101251712033-08-02DP
78883232027-12-04DP
79895892027-12-04DP
91693072027-11-18DPU-3123, U-3541
Pegcetacoplan, Syfovre, Apellis Pharms
81685842027-04-07U-3540, U-3542
90560762026-10-25U-3540
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA54: Pegcetacoplan
HCPCS
No data
Clinical
Clinical Trials
24 clinical trials
View more details
Mock data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Large b-cell lymphoma diffuseD016403C83.3661—113
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Follicular lymphomaD008224C8224———6
Mantle-cell lymphomaD020522C83.133———5
Non-hodgkin lymphomaD008228C85.931———4
B-cell lymphomaD01639322———4
LymphomaD008223C85.911———2
B-cell chronic lymphocytic leukemiaD015451C91.111———2
Waldenstrom macroglobulinemiaD008258C88.011———2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Burkitt lymphomaD002051C83.72————2
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.01————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common namePEGCETACOPLAN
INNpegcetacoplan
Description
Pegcetacoplan, sold under the brand name Empaveli, among others, is a medication used to treat paroxysmal nocturnal hemoglobinuria: ¶1 : Abstract  and geographic atrophy of the retina.: ¶1  Pegcetacoplan is a complement inhibitor.: ¶11 : ¶11 
Classification
Protein
Drug classcomplement ligand inhibitors; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID2019171-69-6
RxCUI—
ChEMBL IDCHEMBL4298211
ChEBI ID—
PubChem CID—
DrugBankDB16694
UNII IDTO3JYR3BOU (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Syfovre - Apellis Pharmaceuticals
$
€
£
₣
Mock data
Subscribe for the real data
Mock data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Additional graphs summarizing 308 documents
View more details
Safety
Black-box Warning
Black-box warning for: Empaveli
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
15 adverse events reported
View more details