Hydroxychloroquine

Hydroxychloroquine, Plaquenil, Sovuna (hydroxychloroquine) is a small molecule pharmaceutical. Hydroxychloroquine was first approved as Plaquenil on 1982-01-01. It is used to treat malaria, photosensitivity disorders, porphyria cutanea tarda, rheumatic diseases, and rheumatoid arthritis amongst others in the USA. The pharmaceutical is active against toll-like receptor 9 and toll-like receptor 7.

Download report

Favorite

COVID-19

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

Mock data
Subscribe for the real data

Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
musculoskeletal diseases	D009140
digestive system diseases	D004066
hereditary congenital and neonatal diseases and abnormalities	D009358
skin and connective tissue diseases	D017437
nutritional and metabolic diseases	D009750
immune system diseases	D007154

Trade Name

FDA

EMA

Hydroxychloroquine, Plaquenil, Sovuna (discontinued: Hydroxychloroquine)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Hydroxychloroquine sulfate

Tradename	Company	Number	Date	Products
PLAQUENIL	Concordia Laboratories	N-009768 RX	1982-01-01	1 products, RLD, RS
SOVUNA	Novitium Pharma	N-214581 RX	2022-01-14	2 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
hydroxychloroquine	ANDA	2024-06-03
hydroxychloroquine sulfate	ANDA	2024-10-15
hydroxychloroquinesulfate	ANDA	2018-07-06
plaquenil	New Drug Application	2024-04-04
sovuna	New Drug Application	2024-09-11

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
malaria	EFO_0001068	D008288	B54
rheumatoid arthritis	EFO_0000685	D001172	M06.9
systemic lupus erythematosus	HP_0002725	D008180	M32
rheumatic diseases	—	D012216	M79.0
porphyria cutanea tarda	—	D017119	E80.1
photosensitivity disorders	HP_0000992	D010787	L57.1

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

P: Antiparasitic products, insecticides and repellents

— P01: Antiprotozoals

— P01B: Antimalarials

— P01BA: Aminoquinoline antimalarials

— P01BA02: Hydroxychloroquine

HCPCS

No data

Clinical

Clinical Trials

585 clinical trials

View more details

Mock data
Subscribe for the real data

Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Covid-19	D000086382	—	—	12	77	102	25	45	232
Arthritis	D001168	HP_0001369	M05-M14	—	11	19	19	13	60
Coronavirus infections	D018352	EFO_0007224	B34.2	4	19	26	5	13	58
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	—	9	18	19	13	57
Sars-cov-2	D000086402	—	—	3	17	12	2	3	32
Infections	D007239	EFO_0000544	—	1	9	14	2	6	29
Systemic lupus erythematosus	D008180	HP_0002725	M32	3	4	6	3	10	25
Syndrome	D013577	—	—	3	12	7	2	4	24
Pneumonia	D011014	EFO_0003106	—	—	6	7	3	8	23
Communicable diseases	D003141	—	—	1	8	7	1	2	17

Show 61 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Severe acute respiratory syndrome	D045169	EFO_0000694	J12.81	2	4	11	—	3	17
Coronavirus	D017934	—	—	—	5	8	—	4	17
Respiratory distress syndrome	D012128	EFO_1000637	J80	1	4	7	—	1	11
Acute lung injury	D055371	EFO_0004610	—	1	4	4	—	—	7
Newborn respiratory distress syndrome	D012127	—	P22	1	4	4	—	—	7
Respiratory tract infections	D012141	—	J06.9	—	—	5	—	—	5
Lupus nephritis	D008181	EFO_0005761	—	—	1	2	—	2	5
Nephritis	D009393	—	N05	—	1	2	—	2	5
Pregnancy rate	D018873	—	—	1	—	1	—	3	5
Respiratory insufficiency	D012131	HP_0002093	J96.9	—	1	4	—	—	4

Show 31 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	14	6	—	—	—	19
Pancreatic neoplasms	D010190	EFO_0003860	C25	7	12	—	—	—	17
Melanoma	D008545	—	—	8	5	—	—	2	12
Breast neoplasms	D001943	EFO_0003869	C50	7	9	—	—	—	12
Lung neoplasms	D008175	HP_0100526	C34.90	4	9	—	—	—	10
Adenocarcinoma	D000230	—	—	6	7	—	—	1	10
Prostatic neoplasms	D011471	—	C61	5	6	—	—	—	9
Colorectal neoplasms	D015179	—	—	2	6	—	—	—	8
Non-small-cell lung carcinoma	D002289	—	—	4	6	—	—	—	7
Carcinoma	D002277	—	C80.0	6	5	—	—	—	7

Show 97 more

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Multiple myeloma	D009101	—	C90.0	4	—	—	—	—	4
Plasma cell neoplasms	D054219	—	—	4	—	—	—	—	4
Immunosuppression therapy	D007165	—	—	1	—	—	—	1	2
Rheumatic diseases	D012216	—	M79.0	1	—	—	—	1	2
Digestive system neoplasms	D004067	—	—	2	—	—	—	—	2
Fibrosis	D005355	—	—	2	—	—	—	—	2
Pancreatic ductal carcinoma	D021441	—	—	1	—	—	—	1	2
Plasmacytoma	D010954	—	C90.3	1	—	—	—	—	1
Respiratory aspiration	D053120	EFO_1001839	—	1	—	—	—	—	1
Myeloid leukemia acute	D015470	—	C92.0	1	—	—	—	—	1

Show 9 more

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Retinal diseases	D012164	HP_0000479	H35.9	—	—	—	—	3	3
Critical illness	D016638	—	—	—	—	—	—	2	2
Diarrhea	D003967	HP_0002014	R19.7	—	—	—	—	2	2
Psoriatic arthritis	D015535	EFO_0003778	L40.5	—	—	—	—	2	2
Macular degeneration	D008268	EFO_0001365	H35.30	—	—	—	—	2	2
Systemic scleroderma	D012595	EFO_0000717	M34.0	—	—	—	—	1	1
Localized scleroderma	D012594	EFO_1001361	L94.0	—	—	—	—	1	1
Diffuse scleroderma	D045743	EFO_0000404	—	—	—	—	—	1	1
Immunotherapy	D007167	—	—	—	—	—	—	1	1
Prevalence	D015995	—	—	—	—	—	—	1	1

Show 31 more

Epidemiology

Epidemiological information for investigational and approved indications

View more details

Drug

General

Drug common name	Hydroxychloroquine
INN	hydroxychloroquine
Description	Hydroxychloroquine is an aminoquinoline that is chloroquine in which one of the N-ethyl groups is hydroxylated at position 2. An antimalarial with properties similar to chloroquine that acts against erythrocytic forms of malarial parasites, it is mainly used as the sulfate salt for the treatment of lupus erythematosus, rheumatoid arthritis, and light-sensitive skin eruptions. It has a role as an antimalarial, an antirheumatic drug, a dermatologic drug and an anticoronaviral agent. It is an aminoquinoline, an organochlorine compound, a primary alcohol, a secondary amino compound and a tertiary amino compound. It is functionally related to a chloroquine. It is a conjugate base of a hydroxychloroquine(2+).
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12

Identifiers

PDB	—
CAS-ID	118-42-3
RxCUI	—
ChEMBL ID	CHEMBL1535
ChEBI ID	5801
PubChem CID	3652
DrugBank	DB01611
UNII ID	4QWG6N8QKH (ChemIDplus, GSRS)

Target

Agency Approved

TLR9

TLR7

Organism

Homo sapiens

Gene name

TLR9

Gene synonyms

NCBI Gene ID

54106

Protein name

toll-like receptor 9

Protein synonyms

CD289

Uniprot ID

Q9NYC3

Mouse ortholog

Tlr9 (81897)

toll-like receptor 9 (Q9EQU3)

Alternate

No data

Variants

No data

Financial

Revenue by drug

€

₣

No data

Estimated US medical usage

Hydroxychloroquine

Total medical expenditures per year (USD, in millions)

Mock data
Subscribe for the real data

Number of persons purchased

Mock data
Subscribe for the real data

Number of purchases

Mock data
Subscribe for the real data

Refill frequency

Mock data
Subscribe for the real data

Price per prescription (USD)

Mock data
Subscribe for the real data

Tabular view

Trends

PubMed Central

Top Terms for Disease or Syndrome:

Mock data
Subscribe for the real data

Additional graphs summarizing 49,764 documents

View more details

Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

Mock data
Subscribe for the real data

63,403 adverse events reported

View more details