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

Stem definition	Drug id	CAS RN
small interfering RNA including siRNA, miRNA and piRNA	5313	1420706-45-1

Description:

Molecule	Description
Synonyms: patisiran ALN-TTR02 ALN-18328 patisiran sodium onpattro	Patisiran is a double-stranded siRNA that causes degradation of mutant and wild-type TTR mRNA through RNA interference, which results in a reduction of serum TTR protein and TTR protein deposits in tissues. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

patisiran
ALN-TTR02
ALN-18328
patisiran sodium
onpattro

Patisiran is a double-stranded siRNA that causes degradation of mutant and wild-type TTR mRNA through RNA interference, which results in a reduction of serum TTR protein and TTR protein deposits in tissues.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

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Date	Agency	Company
Aug. 27, 2018	EMA	ALNYLAM NETHERLANDS B.V.
June 18, 2019	PMDA	ALNYLAM JAPAN K.K.
Oct. 8, 2018	FDA	ALNYLAM PHARMS INC

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FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Infusion related reaction	61.03	41.83	26	232	245495	63243269

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Infusion related reaction	75.33	42.98	31	668	53026	34903206

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Infusion related reaction	74.11	40.36	34	494	230203	79513657
Product dose omission issue	48.08	40.36	26	502	247511	79496349

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N07XX12	NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs
FDA CS	M0406100	RNA, Small Interfering
FDA EPC	N0000193848	Small Interfering RNA
FDA EPC	N0000193849	Transthyretin-directed RNA Interaction
FDA PE	N0000008852	Decreased RNA Integrity
FDA PE	N0000009531	Increased Protein Breakdown

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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
Transthyretin familial amyloid polyneuropathy	indication	42295001
Polyneuropathy in amyloidosis	indication	193187004

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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
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	ONPATTRO	ALNYLAM PHARMS INC	N210922	Aug. 10, 2018	RX	SOLUTION	INTRAVENOUS	8822668	April 15, 2029	TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	ONPATTRO	ALNYLAM PHARMS INC	N210922	Aug. 10, 2018	RX	SOLUTION	INTRAVENOUS	9364435	April 15, 2029	TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	ONPATTRO	ALNYLAM PHARMS INC	N210922	Aug. 10, 2018	RX	SOLUTION	INTRAVENOUS	10240152	Oct. 20, 2029	TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	ONPATTRO	ALNYLAM PHARMS INC	N210922	Aug. 10, 2018	RX	SOLUTION	INTRAVENOUS	8168775	Oct. 20, 2029	TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	ONPATTRO	ALNYLAM PHARMS INC	N210922	Aug. 10, 2018	RX	SOLUTION	INTRAVENOUS	8741866	Oct. 20, 2029	TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	ONPATTRO	ALNYLAM PHARMS INC	N210922	Aug. 10, 2018	RX	SOLUTION	INTRAVENOUS	9234196	Oct. 20, 2029	TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	ONPATTRO	ALNYLAM PHARMS INC	N210922	Aug. 10, 2018	RX	SOLUTION	INTRAVENOUS	8802644	Oct. 21, 2030	TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	ONPATTRO	ALNYLAM PHARMS INC	N210922	Aug. 10, 2018	RX	SOLUTION	INTRAVENOUS	8158601	Nov. 10, 2030	TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	ONPATTRO	ALNYLAM PHARMS INC	N210922	Aug. 10, 2018	RX	SOLUTION	INTRAVENOUS	11079379	Aug. 27, 2035	TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

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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
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	ONPATTRO	ALNYLAM PHARMS INC	N210922	Aug. 10, 2018	RX	SOLUTION	INTRAVENOUS	Aug. 10, 2023	NEW CHEMICAL ENTITY
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	ONPATTRO	ALNYLAM PHARMS INC	N210922	Aug. 10, 2018	RX	SOLUTION	INTRAVENOUS	Aug. 10, 2025	INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
transthyretin (TTR) mRNA	RNA	P02766	TTHY_HUMAN	ANTISENSE INHIBITOR				UNKNOWN	DRUG LABEL

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External reference:

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ID	Source
017680	NDDF
1217021003	SNOMEDCT_US
1386913-72-9	SECONDARY_CAS_RN
2053490	RXNORM
287397	MMSL
34742	MMSL
4037752	VANDF
50FKX8CB2Y	UNII
773605008	SNOMEDCT_US
773608005	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Onpattro	HUMAN PRESCRIPTION DRUG LABEL	1	71336-1000	INJECTION, LIPID COMPLEX	2 mg	INTRAVENOUS	NDA	28 sections
Onpattro	HUMAN PRESCRIPTION DRUG LABEL	1	71336-1000	INJECTION, LIPID COMPLEX	2 mg	INTRAVENOUS	NDA	28 sections
Onpattro	HUMAN PRESCRIPTION DRUG LABEL	1	71336-1000	INJECTION, LIPID COMPLEX	2 mg	INTRAVENOUS	NDA	28 sections

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