pegcetacoplan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5457 2019171-69-6

Description:

MoleculeDescription

Molfile

Synonyms:

  • pegcetacoplan
  • empaveli
  • APL-2
  • aspaveli
Pegcetacoplan binds to complement protein C3 and its activation fragment C3b, thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation. In PNH, extravascular hemolysis (EVH) is facilitated by C3b opsonization while intravascular hemolysis (IVH) is mediated by the downstream membrane attack complex (MAC). Pegcetacoplan acts proximally in the complement cascade controlling both C3b-mediated EVH and terminal complement-mediated IVH.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 13, 2021 EMA SWEDISH ORPHAN BIOVITRUM AB (PUBL)
May 14, 2021 FDA APELLIS PHARMACEUTICALS INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AA54 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
FDA EPC N0000175575 Complement Inhibitor
FDA MoA N0000175974 Complement Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Paroxysmal nocturnal hemoglobinuria indication 1963002 DOID:0060284
Unresolved serious infection caused by Neisseria meningitidis contraindication 23511006
Unresolved serious infection caused by Haemophilus influenzae contraindication 91428005




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1080MG/20ML (54MG/ML) EMPAVELI APELLIS PHARMS N215014 May 14, 2021 RX SOLUTION SUBCUTANEOUS 9169307 Nov. 18, 2027 TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF COMPLEMENT INHIBITOR PEGCETACOPLAN
1080MG/20ML (54MG/ML) EMPAVELI APELLIS PHARMS N215014 May 14, 2021 RX SOLUTION SUBCUTANEOUS 10875893 Nov. 15, 2033 TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN
1080MG/20ML (54MG/ML) EMPAVELI APELLIS PHARMS N215014 May 14, 2021 RX SOLUTION SUBCUTANEOUS 11292815 Nov. 15, 2033 TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN
1080MG/20ML (54MG/ML) EMPAVELI APELLIS PHARMS N215014 May 14, 2021 RX SOLUTION SUBCUTANEOUS 11292815 Nov. 15, 2033 TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN SO AS TO REDUCE THE SENSITIVITY OF CELLS TO COMPLEMENT-DEPENDENT DAMAGE
1080MG/20ML (54MG/ML) EMPAVELI APELLIS PHARMS N215014 May 14, 2021 RX SOLUTION SUBCUTANEOUS 11040107 April 9, 2038 TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN
1080MG/20ML (54MG/ML) EMPAVELI APELLIS PHARMS N215014 May 14, 2021 RX SOLUTION SUBCUTANEOUS 11040107 April 9, 2038 TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN EVERY THREE DAYS
1080MG/20ML (54MG/ML) EMPAVELI APELLIS PHARMS N215014 May 14, 2021 RX SOLUTION SUBCUTANEOUS 11040107 April 9, 2038 TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN TWICE WEEKLY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1080MG/20ML (54MG/ML) EMPAVELI APELLIS PHARMS N215014 May 14, 2021 RX SOLUTION SUBCUTANEOUS May 14, 2026 NEW CHEMICAL ENTITY
1080MG/20ML (54MG/ML) EMPAVELI APELLIS PHARMS N215014 May 14, 2021 RX SOLUTION SUBCUTANEOUS May 14, 2028 TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Complement C3 Unclassified INHIBITOR IC50 6.60 SCIENTIFIC LITERATURE DRUG LABEL

External reference:

IDSource
TO3JYR3BOU UNII
C5418501 UMLSCUI
CHEMBL4298211 ChEMBL_ID
DB16694 DRUGBANK_ID
2557372 RXNORM
346711 MMSL
39544 MMSL
d09749 MMSL
1162412004 SNOMEDCT_US
1162431005 SNOMEDCT_US
4040509 VANDF
018732 NDDF
C000716074 MESH_SUPPLEMENTAL_RECORD_UI
10743 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Empaveli HUMAN PRESCRIPTION DRUG LABEL 1 73606-010 INJECTION, SOLUTION 1080 mg SUBCUTANEOUS NDA 31 sections