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

Stem definition	Drug id	CAS RN
complement receptor antagonists or complement inhibitors	5494	1346623-17-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: avacopan tavneos CCX168	Avacopan is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the anaphylatoxin C5a. Avacopan blocks C5a-mediated neutrophil activation and migration. The precise mechanism by which avacopan exerts a therapeutic effect in patients with ANCA-associated vasculitis has not been definitively established. Molecular weight: 581.66 Formula: C33H35F4N3O2 CLOGP: 7.62 LIPINSKI: 2 HAC: 5 HDO: 2 TPSA: 61.44 ALOGS: -6.42 ROTB: 7 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

avacopan
tavneos
CCX168

Avacopan is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the anaphylatoxin C5a. Avacopan blocks C5a-mediated neutrophil activation and migration. The precise mechanism by which avacopan exerts a therapeutic effect in patients with ANCA-associated vasculitis has not been definitively established.

Molecular weight: 581.66
Formula: C33H35F4N3O2
CLOGP: 7.62
LIPINSKI: 2
HAC: 5
HDO: 2
TPSA: 61.44
ALOGS: -6.42
ROTB: 7

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
60	mg	O

ADMET properties:

None

Approvals:

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Date	Agency	Company
Jan. 11, 2022	EMA	Vifor Fresenius Medical Care Renal Pharma France
Oct. 7, 2021	FDA	CHEMOCENTRYX
Sept. 27, 2021	PMDA	KISSEI PHARMACEUTICAL CO., LTD.

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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:

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Source	Code	Description
ATC	L04AA59	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
FDA EPC	N0000193973	Complement 5a Receptor Antagonist
FDA MoA	N0000182141	Cytochrome P450 3A4 Inhibitors
FDA MoA	N0000193974	Complement 5a Receptor Antagonists

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Granulomatosis with polyangiitis	indication	195353004	DOID:12132
Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis)	indication	722191003
Microscopic polyangiitis	indication	1144805008

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG	TAVNEOS	CHEMOCENTRYX	N214487	Oct. 7, 2021	RX	CAPSULE	ORAL	11603356	May 29, 2041	AN ADJUNCTIVE TREATMENT OF ADULT PATIENTS WITH TAVNEOS (AVACOPAN) WITH SEVERE ACTIVE ANCA-ASSOCIATED VASCULITIS (GPA AND MPA) IN COMBINATION WITH STANDARD THERAPY INCLUDING GLUCOCORTICOIDS

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
10MG	TAVNEOS	CHEMOCENTRYX	N214487	Oct. 7, 2021	RX	CAPSULE	ORAL	Oct. 7, 2026	NEW CHEMICAL ENTITY
10MG	TAVNEOS	CHEMOCENTRYX	N214487	Oct. 7, 2021	RX	CAPSULE	ORAL	Oct. 7, 2028	AS AN ADJUNCTIVE TREATMENT OF ADULT PATIENTS WITH SEVERE ACTIVE ANTI-NEUTROPHIL CYTOPLASMIC AUTOANTIBODY (ANCA)-ASSOCIATED VASCULITIS (GRANULOMATOSIS WITH POLYANGIITIS [GPA] AND MICROSCOPIC POLYANGIITIS [MPA])