Volanesorsen - PharmaKB

Volanesorsen

Waylivra (volanesorsen) is an oligonucleotide pharmaceutical. Volanesorsen was first approved as Waylivra on 2019-05-03. It has been approved in Europe to treat hyperlipoproteinemia type i.

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Events

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
hereditary congenital and neonatal diseases and abnormalities	D009358
nutritional and metabolic diseases	D009750

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Drug Products

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New Drug Application (NDA)

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EMA

Brand Name	Status	Last Update
acne free blackhead removing scrub 2 salicylic acid with charcoal	C200263	2025-07-24
clear days ahead	C200263	2025-12-17
lactic acid free for sportswoman synergy	OTC monograph not final	2017-01-01
lactic acid free m synergy	OTC monograph not final	2016-10-24
oil free acne scrub	OTC monograph final	2010-07-08
peach slices 3 step acne starter kit	C200263	2024-08-14
premasol - sulfite-free (amino acid)	ANDA	2022-08-04
walgreens oil-free acne wash	C200263	2024-06-03

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Agency Specific

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Patent Expiration

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ATC Codes

C: Cardiovascular system drugs

— C10: Lipid modifying agents

— C10A: Lipid modifying agents, plain

— C10AX: Other lipid modifying agents in atc

— C10AX18: Volanesorsen

HCPCS

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Clinical

Clinical Trials

1799 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Breast neoplasms	D001943	EFO_0003869	C50	9	21	17	3	13	61
Healthy volunteers/patients	—	—	—	34	3	1	2	22	61
Diabetes mellitus	D003920	EFO_0000400	E08-E13	3	11	3	11	28	53
Colorectal neoplasms	D015179	—	—	7	27	9	1	9	50
Obesity	D009765	EFO_0001073	E66.9	3	4	3	5	33	45
Hepatitis c	D006526	—	B19.2	1	20	20	3	1	41
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	1	7	1	7	25	39
Hiv infections	D015658	EFO_0000764	B20	4	7	14	7	6	37
Chronic hepatitis c	D019698	EFO_0004220	B18.2	—	14	19	1	2	33
Insulin resistance	D007333	EFO_0002614	E88.819	—	8	—	3	22	33

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myeloid leukemia acute	D015470	—	C92.0	7	20	1	—	2	27
Leukemia	D007938	—	C95	4	9	8	—	2	22
Prostatic neoplasms	D011471	—	C61	3	6	6	—	6	20
Stomach neoplasms	D013274	EFO_0003897	C16	4	9	3	—	5	19
Pancreatic neoplasms	D010190	EFO_0003860	C25	5	8	2	—	4	17
Liver neoplasms	D008113	EFO_1001513	C22.0	2	7	5	—	5	17
Myelodysplastic syndromes	D009190	—	D46	6	8	3	—	—	16
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	2	3	8	—	3	15
Hepatocellular carcinoma	D006528	—	C22.0	1	5	5	—	5	14
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	4	7	2	—	1	13

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Melanoma	D008545	—	—	4	10	—	—	3	16
Overweight	D050177	—	E66.3	2	1	—	—	9	12
Hypersensitivity	D006967	EFO_0003785	T78.40	1	3	—	—	5	9
Hematologic neoplasms	D019337	—	—	2	6	—	—	1	8
Esophageal neoplasms	D004938	—	C15	4	3	—	—	2	8
Renal cell carcinoma	D002292	EFO_0000376	—	1	6	—	—	1	8
Myeloid leukemia	D007951	—	C92	3	3	—	—	—	6
Glioblastoma	D005909	EFO_0000515	—	2	3	—	—	1	6
Acute kidney injury	D058186	—	N17	—	2	—	—	4	6
Metabolic diseases	D008659	EFO_0000589	E88.9	—	1	—	—	5	6

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Therapeutic equivalency	D013810	—	—	3	—	—	—	1	4
Urticaria	D014581	EFO_0005531	L50	1	—	—	—	2	3
Hypoxia	D000860	—	R09.02	2	—	—	—	1	3
Biliary tract neoplasms	D001661	—	C24.9	1	—	—	—	2	3
Schizophrenia	D012559	EFO_0000692	F20	2	—	—	—	1	3
Affect	D000339	—	—	1	—	—	—	1	2
Gastric bypass	D015390	EFO_0005244	—	1	—	—	—	1	2
Alveolar soft part sarcoma	D018234	—	—	2	—	—	—	—	2
Neurofibrosarcoma	D018319	—	—	2	—	—	—	—	2
Hypercapnia	D006935	—	—	1	—	—	—	1	2

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Exercise	D015444	EFO_0000483	—	—	—	—	—	8	8
Phenylketonurias	D010661	—	E70.0	—	—	—	—	8	8
Wounds and injuries	D014947	—	T14.8	—	—	—	—	6	6
Wound healing	D014945	GO_0042060	—	—	—	—	—	6	6
Myopia	D009216	EFO_0003927	H52.1	—	—	—	—	4	4
Fatigue	D005221	—	R53.83	—	—	—	—	4	4
Irritable bowel syndrome	D043183	EFO_0000555	K58	—	—	—	—	4	4
Biological availability	D001682	—	—	—	—	—	—	4	4
Gastrointestinal diseases	D005767	—	—	—	—	—	—	4	4
Micronutrients	D018977	—	—	—	—	—	—	3	3

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Volanesorsen
INN	volanesorsen
Description	Volanesorsen, sold under the brand name Waylivra, is a triglyceride-reducing drug. It is a second-generation 2'-O-methoxyethyl (2'-MOE) chimeric antisense therapeutic oligonucleotide (ASO) that targets the messenger RNA for apolipoprotein C3 (apo-CIII).
Classification	Oligonucleotide
Drug class	antisense oligonucleotides
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	—