Remdesivir - PharmaKB

Veklury(remdesivir)

Veklury (remdesivir) is a small molecule pharmaceutical. Remdesivir was first approved as Veklury on 2020-07-03. It is used to treat coronavirus infections and virus diseases in the USA. It is known to target ORF1a polyprotein;ORF1ab polyprotein.

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COVID-19

FDA Novel Drug Approvals 2020

Case Study: COVID-19

Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239

Trade Name

FDA

EMA

Veklury

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Remdesivir

Tradename	Company	Number	Date	Products
VEKLURY	Gilead Sciences	N-214787 RX	2020-10-22	2 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
veklury	New Drug Application	2024-07-08

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
coronavirus infections	EFO_0007224	D018352	B34.2
virus diseases	—	D014777	B34

Agency Specific

FDA

EMA

Expiration	Code
REMDESIVIR, VEKLURY, GILEAD SCIENCES INC
2025-10-22	NCE
2025-04-25	NPP
2025-01-21	D-183

Patent Expiration

Patent	Expires	Flag	FDA Information
Remdesivir, Veklury, Gilead Sciences Inc
11491169	2041-05-28		U-3484, U-3485
10675296	2038-07-10	DP
11266681	2038-07-10		U-2984, U-3249, U-3367, U-3368
10695361	2036-09-16		U-2984, U-3249, U-3367, U-3368
11007208	2036-09-16		U-2984, U-3249, U-3367, U-3368
11382926	2036-09-16		U-3367, U-3368
9724360	2035-10-29	DS, DP
9949994	2035-10-29	DP
11492353	2031-12-08	DP
10065958	2031-09-16	DP
8008264	2029-09-06	DS, DP
RE46762	2029-04-22	DS, DP
8318682	2029-04-22	DS, DP

ATC Codes

J: Antiinfectives for systemic use

— J05: Antivirals for systemic use

— J05A: Direct acting antivirals

— J05AB: Nucleosides and nucleotides excl. reverse transcriptase inhibitors

— J05AB16: Remdesivir

HCPCS

No data

Clinical

Clinical Trials

121 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Covid-19	D000086382	—	—	8	30	48	6	31	113
Pneumonia	D011014	EFO_0003106	—	1	1	5	1	5	13
Post-acute covid-19 syndrome	D000094024	—	—	—	—	—	2	—	2

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Coronavirus infections	D018352	EFO_0007224	B34.2	1	4	4	—	7	15
Infections	D007239	EFO_0000544	—	1	1	3	—	5	9
Communicable diseases	D003141	—	—	1	1	2	—	4	7
Respiratory distress syndrome	D012128	EFO_1000637	J80	1	3	3	—	1	7
Sars-cov-2	D000086402	—	—	1	1	3	—	1	6
Virus diseases	D014777	—	B34	2	2	1	—	2	6
Severe acute respiratory syndrome	D045169	EFO_0000694	J12.81	2	2	2	—	1	6
Viral pneumonia	D011024	EFO_0007541	J12.9	—	—	1	—	3	4
Ebola hemorrhagic fever	D019142	EFO_0007243	A98.4	—	3	1	—	—	3
Acute lung injury	D055371	EFO_0004610	—	—	2	1	—	—	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Acute kidney injury	D058186	HP_0001919	N17	—	1	—	—	1	2
Hiv infections	D015658	EFO_0000764	B20	—	1	—	—	—	1
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	—	1	—	—	—	1
X-linked combined immunodeficiency diseases	D053632	EFO_1001451	—	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Respiratory tract infections	D012141	—	J06.9	2	—	—	—	2	4
Syndrome	D013577	—	—	1	—	—	—	1	2
Nerve degeneration	D009410	HP_0002180	—	1	—	—	—	—	1
Neuroinflammatory diseases	D000090862	—	—	1	—	—	—	—	1
Disease progression	D018450	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hemorrhage	D006470	MP_0001914	R58	—	—	—	—	2	2
Coronavirus	D017934	—	—	—	—	—	—	2	2
Respiratory insufficiency	D012131	HP_0002093	J96.9	—	—	—	—	2	2
Immunocompromised host	D016867	—	D84.9	—	—	—	—	2	2
Critical illness	D016638	—	—	—	—	—	—	1	1
Cytokine release syndrome	D000080424	—	D89.83	—	—	—	—	1	1
Heart failure	D006333	HP_0001635	I50	—	—	—	—	1	1
Hypertension	D006973	EFO_0000537	I10	—	—	—	—	1	1
Menorrhagia	D008595	EFO_0003945	N92.0	—	—	—	—	1	1
Hemophilia a	D006467	EFO_0007267	D66	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Remdesivir
INN	—
Description	Remdesivir is a carboxylic ester resulting from the formal condensation of the carboxy group of N-[(S)-{[(2R,3S,4R,5R)-5-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]-L-alanine with the hydroxy group of 2-ethylbutan-1-ol. A broad-spectrum antiviral prodrug with potent in vitro antiviral activity against a diverse panel of RNA viruses such as Ebola virus, MERS-CoV and SARS-CoV. It is currently in Phase III clinical trials for the treatment of Covid-19 in adults. It has a role as an antiviral drug, a prodrug and an anticoronaviral agent. It is a carboxylic ester, a pyrrolotriazine, a nitrile, a phosphoramidate ester, a C-nucleoside and an aromatic amine. It is functionally related to a GS-441524.
Classification	Small molecule
Drug class	antivirals: adenosine analogs acting as RNA polymerase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CCC(CC)COC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@](C#N)(c2ccc3c(N)ncnn23)[C@H](O)[C@@H]1O)Oc1ccccc1