Data updated: Nov 8, 2026
CHLOROQUINE PHOSPHATE · Hikma
Infectious Disease
Approved 1949-10-31
Development Insights
University of Oxford conducting 7 trials (12%)
49 indications explored (Broad Platform)
→ malaria (9 trials)
→ vivax malaria (8 trials)
→ malaria, vivax (5 trials)
8
Indications
--
Phase 3 Trials
77
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1949-10-31
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
Hikma NATCO PHARMA LTD IPCA LABS LTD WATSON LABS IMPAX LABS PUREPAC PHARM COHANCE LIFESCIENCES Teva MD PHARM
Active Ingredient: CHLOROQUINE PHOSPHATE
Website: ↗
CHLOROQUINE PHOSPHATE Approval History
1975
1976
1977
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1982
1983
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1985
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1988
1989
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2015
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2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
154 FDA actions from 1974 to 2026
Oct 2026 SUPPL
Label · Labeling
Oct 2026 SUPPL
Label · Labeling
Feb 2024 SUPPL
Label · Labeling
Jul 2023 SUPPL
Label
Mar 2023 SUPPL
Mfg
May 2022 SUPPL
Label
Mar 2022 SUPPL
Label
Mar 2022 SUPPL
Label
Mar 2022 SUPPL
Label
Sep 2021 ORIGINAL
Update
May 2020 SUPPL
Label
Apr 2020 SUPPL
Label
Apr 2020 SUPPL
Label
Feb 2016 SUPPL
Label
Aug 2015 SUPPL
Label
Jan 2011 ORIGINAL
Update
Dec 2009 ORIGINAL
Update
May 2007 SUPPL
Label
Mar 2006 SUPPL
Label
Sep 2005 SUPPL
Label
Aug 2003 ORIGINAL
Update
Jul 2001 SUPPL
Mfg
Nov 2000 SUPPL
Mfg
May 2000 SUPPL
Mfg
Sep 1999 SUPPL
Mfg
Oct 1998 SUPPL
Mfg
Sep 1997 SUPPL
Mfg
Jul 1997 SUPPL
Mfg
Oct 1996 SUPPL
Label
Oct 1994 SUPPL
Label
Oct 1993 SUPPL
Mfg
Sep 1993 SUPPL
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Nov 1992 SUPPL
Mfg
Jan 1992 SUPPL
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Dec 1991 SUPPL
Mfg
Nov 1991 SUPPL
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May 1991 SUPPL
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Apr 1991 SUPPL
Mfg
Mar 1991 SUPPL
Mfg
Jan 1991 SUPPL
Mfg
Jun 1990 SUPPL
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Nov 1989 SUPPL
Label
Sep 1989 SUPPL
Label
Aug 1989 SUPPL
Label
Jul 1989 SUPPL
Update
Jan 1989 SUPPL
Mfg
Dec 1988 SUPPL
Update
Dec 1988 SUPPL
Label
Nov 1988 SUPPL
Label
Apr 1988 SUPPL
Mfg
Jul 1987 SUPPL
Mfg
Jun 1987 SUPPL
Mfg
Jun 1986 SUPPL
Mfg
Dec 1985 SUPPL
Mfg
Jun 1985 SUPPL
Mfg
Jan 1985 SUPPL
Mfg
Nov 1984 SUPPL
Mfg
Feb 1984 SUPPL
Mfg
Jan 1984 SUPPL
Mfg
Jan 1983 SUPPL
Mfg
Dec 1982 ORIGINAL
Update
Jan 1982 ORIGINAL
Update
Jul 1975 ORIGINAL
Update
Dec 1974 ORIGINAL
Update
What CHLOROQUINE PHOSPHATE Treats
8 FDA approvalsOriginally approved for its first indication in 1974 . Covers 8 distinct patient populations.
- Other (8)
Other
(8 approvals)- • Approved indication (Dec 1974)
- • Approved indication (Jul 1975)
- • Approved indication (Jan 1982)
- • Approved indication (Dec 1982)
- • Approved indication (Aug 2003)
- • Approved indication (Dec 2009)
- • Approved indication (Jan 2011)
- • Approved indication (Sep 2021)
📋
Clinical Trial Registry
63 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT06076837 | HRI-2023 Magnificent 7 | Ph 1 | terminated | The Seven Trial: Exploiting the Unfolded Protein Response |
| NCT06083688 | 23-048 | Ph 4 | completed | Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi |
| NCT06666491 | 208550 | Ph 3 | recruiting | An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older |
| NCT04704999 SEADOT | MAL20005 21-0023 | Ph 4 | recruiting | Southeast Asia Dose Optimization of Tafenoquine |
| NCT04349371 results posted | AAAS9992 | Ph 2 | terminated | Saved From COVID-19 - Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID |
| NCT03529396 | CAAE: 70177317.1.0000.0005 | Ph 2 | completed | Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients |
| NCT04397679 | 2018-148 | Ph 1 | terminated | Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma |
| NCT02389374 results posted | PR-14053 | Ph 4 | completed | A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh |
| NCT01894633 CLQ | CD-449-08 | Ph 2 | terminated | Study of Whole-brain Irradiation With Chloroquine for Brain Metastases |
| NCT02432417 | CHLOROBRAINII | Ph 2 | withdrawn | The Addition of Chloroquine to Chemoradiation for Glioblastoma, |
| NCT06044805 CQ+PQ | EPHI-IRB-294-2 | Ph 4 | completed | Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax |
| NCT05980156 | HP-00098250v3 | Ph 4 | completed | Comparing Chemoprevention Drugs for School-based Malaria Control |
| NCT05244954 | HP-00098250 | Ph 4 | completed | Comparing Chemoprevention Approaches for School-based Malaria Control |
| NCT03952650 results posted | 999919099 19-I-N099 | Ph 1, Ph 2 | completed | Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa... |
| NCT03449758 SariPRO results posted | SARILL08755 U1111-1197-7699, 2017-002951-27 | Ph 4 | completed | Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis |
| NCT04351295 | faviprevir covid | Ph 2, Ph 3 | completed | Efficacy of Faviprevir in COVID-19 Treatment |
| NCT04627467 TS-COVID | FVL-1567 | Ph 2 | completed | Prevention With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19) (TS-COVID) |
| NCT03083847 results posted | 170067 17-I-0067 | Ph 1 | completed | Dose Escalation PfSPZ-CVac |
| NCT04328493 VICO | COVID | Ph 2 | completed | The Vietnam Chloroquine Treatment on COVID-19 |
| NCT02564471 MALRAB results posted | 790117 | Ph 4 | completed | Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis. |
| NCT04420247 | CLOROTRIAL | Ph 3 | completed | Efficacy of Chloroquine or Hydroxychloroquine in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19 |
| NCT04346667 PEACE | NBC-COVID19-02 | Ph 4 | terminated | Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds |
| NCT04351191 PRECISE | NBC-COVID1902 | Ph 4 | terminated | PRophylaxis of Exposed COVID-19 Individuals With Mild Symptoms Using choloroquinE Compounds |
| NCT04331600 | WROCLAW CORONA STUDY 2020 | Ph 4 | completed | Chloroquine as Antiviral Treatment in Coronavirus Infection 2020 |
| NCT02563496 results posted | 113577 | Ph 2 | completed | A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria |
| NCT04333628 | EMC 0045-20 | Ph 2, Ph 3 | terminated | Chloroquine for Mild Symptomatic and Asymptomatic COVID-19 |
| NCT02876549 GAP | BAKMAL1601 | Ph 4 | completed | G6PD Assessment Before Primaquine for Radical Treatment of Vivax Malaria |
| NCT01438177 results posted | 10-02008 | Ph 2 | terminated | Chloroquine in Combination With VELCADE and Cyclophosphamide for Relapsed and Refractory Multiple Myeloma |
| NCT02378532 CHLOROBRAIN | CHLOROBRAIN | Ph 1 | completed | The Addition of Chloroquine to Chemoradiation for Glioblastoma |
| NCT03070470 results posted | 16-086D SCR-004 | Ph 1 | completed | CiPA Phase 1 ECG Biomarker Validation Study |
| NCT02773979 | 11-0042 HHSN272201300019I | Ph 1 | completed | PfSPZ Challenge in Healthy Malaria-Naïve Adults in the United States |
| NCT02996695 | 15-0052 HHSN272201300022I | Ph 1 | completed | Safety and Efficacy of Sanaria's PfSPZ-CVac in Malian Adults |
| NCT02071537 | UCCI-EXP-13-01 | Ph 1 | completed | Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors |
| NCT02932007 | Chloroquine AF | Ph 2 | recruiting | Chloroquine for Patients With Symptomatic Persistent Atrial Fibrillation: A Prospective Pilot Study |
| NCT01178021 VRA | BAKMAL0903 | Ph 4 | completed | Estimating the Risk of Plasmodium Vivax Relapses in Afghanistan |
| NCT01941095 results posted | ML28695 2013-000359-42 | Ph 3 | completed | A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis |
| NCT00972725 results posted | 113165 | Ph 2 | completed | Evaluation of the Immune Response of a HIV Candidate Vaccine After Administration of One Chloroquine Dose |
| NCT02216123 results posted | 116564 | Ph 3 | completed | Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria |
| NCT02698748 Cloroquina | CNBS (173/CNBS/13) | Ph 2, Ph 3 | completed | Evaluating the Role of Chloroquine for Malaria Elimination |
| NCT01575782 Chloroquine | CHLOROQUINE I-III | Ph 1 | terminated | Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer |
| NCT02001012 CAN KNOW | NMRR-13-18375 | Ph 3 | completed | P. Knowlesi Trial of Artemether-lumefantrine vs Chloroquine |
| NCT01205178 | 110027 | Ph 1 | completed | G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine) |
| NCT01680406 | CDC-CGH-6338 | Ph 4 | completed | Ethiopia Antimalarial in Vivo Efficacy Study 2012 |
| NCT01443130 results posted | 09-0112 4R01AI104702-04 | Ph 3 | completed | Chloroquine for Malaria in Pregnancy |
| NCT01887821 | 07MA | Ph 4 | completed | Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam |
| NCT01640574 | SMRU1102 | Ph 3 | completed | Comparison Between 7 and 14 Day Primaquine Combined With Dihydroartemisinin-piperaquine or 3 Day Chloroquine Radical Cure of P. Vivax (BPD) |
| NCT02691910 | 404067/2012-3 550.565 | Ph 2, Ph 3 | completed | Efficacy of Chloroquine (CQ) Alone Compared to Concomitant CQ and Primaquine for Plasmodium Vivax Infection |
| NCT01785979 LiHMS | LiHMS | Ph 3 | withdrawn | Prednisone Plus Chloroquine for the Treatment of Hyper-reactive Malarial Splenomegaly |
| NCT02192944 | FTM1401 | Ph 4 | completed | Comparison of the ECG Effects Related to Pharmacokinetic Profile of Chloroquine and Piperaquine |
Showing 50 of 63 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CHLOROQUINE PHOSPHATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment