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AboutPricing
Drug ReportsPegcetacoplan
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. It is known to target complement C3.
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FDA Novel Drug Approvals 2021
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
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3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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 Application2024-06-27
syfovreNew Drug Application2024-08-19
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
118448412038-12-09DPU-3172, U-3173, U-3174
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
116614412033-01-13DPU-3124, U-3540
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
27 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Paroxysmal hemoglobinuriaD006457Orphanet_447D59.12222—28
HemoglobinuriaD006456—R82.3222—28
Macular degenerationD008268EFO_0001365H35.30213—16
Geographic atrophyD057092——113—16
AtrophyD001284——113—16
GlomerulonephritisD005921HP_0000099N05—22—15
Membranoproliferative glomerulonephritisD015432———22—15
Hemolytic anemia autoimmuneD000744EFO_1001264D59.12—11——2
Neoplasm metastasisD009362EFO_0009708———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Wet macular degenerationD057135EFO_0004683—21———2
RecurrenceD012008———2———2
Amyotrophic lateral sclerosisD000690HP_0007354G12.21—1———1
Motor neuron diseaseD016472EFO_0003782G12.2—1———1
SclerosisD012598———1———1
Kidney transplantationD016030———1———1
Kidney diseasesD007674EFO_0003086N08—1———1
Iga glomerulonephritisD005922EFO_0004194——1———1
Membranous glomerulonephritisD015433EFO_0004254N03.2—1———1
Lupus nephritisD008181EFO_0005761——1———1
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Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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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 and geographic atrophy of the retina. Pegcetacoplan is a complement inhibitor.
Classification
Protein
Drug classcomplement ligand inhibitors; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
Image (chem structure or protein)Loading
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
C3
C3
Organism
Homo sapiens
Gene name
C3
Gene synonyms
CPAMD1
NCBI Gene ID
718
Protein name
complement C3
Protein synonyms
acylation-stimulating protein cleavage product, C3 and PZP-like alpha-2-macroglobulin domain-containing protein 1, C3a anaphylatoxin, complement component 3, complement component C3a, complement component C3b, epididymis secretory sperm binding protein Li 62p, prepro-C3
Uniprot ID
P01024
Mouse ortholog
C3 (12266)
complement C3 (Q80XP1)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Syfovre – Apellis Pharmaceuticals
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 981 documents
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Safety
Black-box Warning
Black-box warning for: Empaveli
Adverse Events
Top Adverse Reactions
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477 adverse events reported
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