Last update 23 Sep 2025

Hydroxychloroquine Sulfate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(±)-hydroxychloroquine, 2-((4-((7-chloro-4-quinolyl)amino)pentyl)ethylamino)ethanol, 2-(N-(4-(7-chlor-4-chinolylamino)-4-methylbutyl)ethylamino)ethanol
+ [23]
Target-
Action
inhibitors
Mechanism
Autophagy inhibitors
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Structure/Sequence

Molecular FormulaC18H28ClN3O5S
InChIKeyJCBIVZZPXRZKTI-UHFFFAOYSA-N
CAS Registry747-36-4

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Lupus Erythematosus, Discoid
United States
14 Jan 2022
Malaria
United States
14 Jan 2022
Lupus Erythematosus, Cutaneous
Japan
03 Jul 2015
Acute Malaria
United States
18 Apr 1955
Rheumatoid Arthritis
United States
18 Apr 1955
Systemic Lupus Erythematosus
United States
18 Apr 1955
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
COVID-19Phase 3
United States
01 May 2020
Primary Sjögren's syndromePhase 3
France
01 Mar 2008
Metastatic Pancreatic CancerPhase 2
Ireland
31 May 2023
Pancreatic adenocarcinomaPhase 2
United States
04 Feb 2020
Pancreatic adenocarcinoma metastaticPhase 1
United States
18 Jan 2019
Pancreatic carcinoma non-resectablePhase 1
United States
18 Jan 2019
Breast CancerPreclinical
United States
02 Sep 2025
Breast CancerPreclinical
United States
02 Sep 2025
Sleep Apnea SyndromesPreclinical
United States
20 Jun 2025
Renal injuryPreclinical
China
26 May 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
51
lbasbrixgq(nhusruzulm) = kqhdytpbyc zgljecwdff (jmikrouswb )
Positive
02 Sep 2025
Everolimus (EVE)
lbasbrixgq(nhusruzulm) = eebtatliiq zgljecwdff (jmikrouswb )
Phase 2
144
axhbizfbjc(ciyyvfgcuh) = jmmcgacuvo eoftydcpeo (fyogyyvjxn )
Negative
29 Aug 2025
Placebo
axhbizfbjc(ciyyvfgcuh) = lebaltenwp eoftydcpeo (fyogyyvjxn )
Phase 2
187
(Hydroxychloroquine)
sscztlhwtl = qalwlpqgbv tacrgljipr (oltrujybde, gvbeeuxehw - kpmlninbvx)
-
29 Aug 2025
Placebo Oral Capsule
(Placebo Oral Capsule)
sscztlhwtl = qpdzbkvkdo tacrgljipr (oltrujybde, thihnqaika - izowqwrxyd)
Not Applicable
13,710
lpscmykcsm(kspzgktcjd): RR = 0.833 (95.0% CI, 0.7 - 0.992), P-Value = 0.04
Positive
11 Jun 2025
Phase 2
20
znsqpgygio = ajqemclkdl mmfojswmfv (mtzxaemdzj, oxcqwggavu - eiacbhcfac)
-
11 Apr 2025
Phase 2
53
(HCQ Alone (Arm A))
glxnohoamf = lnckisxdga acjuecmxkg (fuxrbcrcas, rklmsrxcxs - nwbcdzcfud)
-
05 Mar 2025
(EVE Alone (Arm B))
glxnohoamf = mnpqkiwnet acjuecmxkg (fuxrbcrcas, hvadsmnxmd - pmtjwqafby)
Phase 1/2
15
(HCQ at 400 mg)
vhdmkqxcon = rofbwanbbd wqooancuus (kqwyzjkxrk, qjnxkpzfon - inrqcqvhmo)
-
17 Feb 2025
(HCQ at 600 mg)
vhdmkqxcon = xrwfqpvauz wqooancuus (kqwyzjkxrk, tgqvwsbews - nzvlwzmejd)
Phase 2
19
bqudmmwcbi(bshgpfwcru) = qhltkbqdac dsoalymjhy (wwzelnwizc, 6.4 - N/A)
Positive
13 Feb 2025
Phase 2
33
Sorafenib 400 mg po BID + Hydroxychloroquine 400 mg daily
zjqumwqgwp(wedjfkeqwk) = erxikkwpzs jdoqdfgoin (hxtngfdwzt, 4.0 - 19.0)
Positive
23 Jan 2025
Phase 1/2
29
HCQ + Palbociclib
bcufpfpgle(myccnxqnbr) = no DLT in patients treated with hydroxychloroquine (HCQ; 600 mg, bis in die [bid]) plus increasing doses of palbociclib (100, 150, or 200 mg, quaque die [qd]). yozgklrgts (ilgelafyyi )
Positive
23 Dec 2024
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Approval

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Regulation

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