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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Financial
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
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Start date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| hemic and lymphatic diseases | D006425 |
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 |
|---|---|---|---|---|
| EMPAVELI | Apellis Pharmaceuticals | N-215014 RX | 2021-05-14 | 1 products, RLD, RS |
| SYFOVRE | Apellis Pharmaceuticals | N-217171 RX | 2023-02-17 | 1 products, RLD, RS |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PEGCETACOPLAN, EMPAVELI, APELLIS PHARMS | |||
| 2028-05-14 | ODE-351 | ||
| 2026-05-14 | NCE | ||
| 2026-02-08 | M-288 | ||
PEGCETACOPLAN, SYFOVRE, APELLIS PHARMS | |||
| 2026-05-14 | NCE | ||
| 2026-02-22 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Pegcetacoplan, Empaveli, Apellis Pharms | |||
| 11844841 | 2038-12-09 | DP | U-3172, U-3173, U-3174 |
| 11040107 | 2038-04-09 | DP | U-3172, U-3173, U-3174 |
| 10035822 | 2033-11-15 | DP | |
| 10875893 | 2033-11-15 | DP | U-3124, U-3540 |
| 11292815 | 2033-11-15 | DS, DP | U-3124, U-3354, U-3540 |
| 10125171 | 2033-08-02 | DP | |
| 11661441 | 2033-01-13 | DP | U-3124, U-3540 |
| 7888323 | 2027-12-04 | DP | |
| 7989589 | 2027-12-04 | DP | |
| 9169307 | 2027-11-18 | DP | U-3123, U-3541 |
| Pegcetacoplan, Syfovre, Apellis Pharms | |||
| 8168584 | 2027-04-07 | U-3540, U-3542 | |
| 9056076 | 2026-10-25 | U-3540 | |
HCPCS
No data
Clinical
Clinical Trials
35 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hemolytic anemia autoimmune | D000744 | EFO_1001264 | D59.10 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | 1 | — | — | — | 1 |
| Thrombotic microangiopathies | D057049 | — | M31.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Paroxysmal hemoglobinuria | D006457 | Orphanet_447 | D59.12 | — | — | — | — | 1 | 1 |
| Hemoglobinuria | D006456 | — | R82.3 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pegcetacoplan |
| INN | pegcetacoplan |
| 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 class | complement 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-ID | 2019171-69-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4298211 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16694 |
| UNII ID | TO3JYR3BOU (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
C3
C3
Organism
Homo sapiens
Gene name
C3
Gene synonyms
CPAMD1
NCBI Gene ID
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
Mouse ortholog
C3 (12266)
complement C3 (Q80XP1)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Syfovre – Apellis Pharmaceuticals
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,406 documents
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Safety
Black-box Warning
Black-box warning for: Empaveli
Adverse Events
Top Adverse Reactions
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1,358 adverse events reported
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