Hydroxychloroquine — drug

Regulatory

Approvals (2)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. • Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. • Treatment of rheumatoid arthritis in adults. • Treatment of systemic lupus erythematosus in adults. • Treatment of chronic discoid lupus erythematosus in adults. • Limitations of Use • : SOVUNA is not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.	approved	Jan 14, 2022	openfda
US FDA	—	Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale , and Plasmodium vivax in adult and pediatric patients. • Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. • Treatment of rheumatoid arthritis in adults. • Treatment of systemic lupus erythematosus in adults. • Treatment of chronic discoid lupus erythematosus in adults. • Limitations of Use • : PLAQUENIL is not recommended for the: • Treatment of complicated malaria. • Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. • Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. • Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. • Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	15	6	1	85	2	US	Apr 18, 1955	2007-07
Malignant Breast Neoplasm	Phase2	Phase 2	3	1	0	8	0	—	—	2009-02
Malignant Lung Neoplasm	Phase2	Phase 2	2	1	0	6	0	—	—	2007-07
Malignant Ovarian Neoplasm	Phase2	Phase 2	2	2	0	2	0	—

Curated evidence

Clinical evidence (1)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
KRAS G12D1
Bevacizumab + Binimetinib

Clinical trials

Trials with this intervention (85)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 85 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04464759	A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma(LIMIT)	active not recruiting	Phase 1 / Phase 2	41	Ravi Amaravadi, MDOTHER	1	Sep 21, 2026	clinicaltrials
NCT07825454	Pilot Study of Hydroxychloroquine for the Treatment of AIMSS(AIMSS)