CLINICAL TRIALS PROFILE FOR HYDROXYCHLOROQUINE SULFATE

All Clinical Trials for HYDROXYCHLOROQUINE SULFATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03377179 ↗	A Study of ABC294640 (Yeliva ®) Alone and in Combination With Hydroxychloroquine Sulfate in Treatment of Patients With Advanced Cholangiocarcinoma	Recruiting	RedHill Biopharma Limited	Phase 2	2018-03-07	ABC-108 is a single-arm Phase IIA clinical study of ABC294640 (Yeliva ®, opaganib) alone and in combination with hydroxychloroquine sulfate (HCQ) in the treatment of cholangiocarcinoma (CCA). In Part 1 of this clinical study, all participants will be receiving ABC294640 and in Part 2 all participants will be receiving ABC294640 and HCQ to explore the drugs activity signal in CCA. The study drug, ABC294640 is an orally available inhibitor of the enzyme sphingosine kinase-2 (SK2). SK2 is an innovative target for anti-cancer therapy because of its critical role in sphingolipid metabolism, which is known to regulate tumor cell death and proliferation. ABC294640 also inhibits proliferation and induces apoptosis of cholangiocarcinoma cell lines. Furthermore, in a recent Phase I trial, ABC294640 demonstrated clinical activity in CCA patients. HCQ, is an orally available, FDA approved therapy for the treatment of malaria as well as discoid and systemic lupus erythematosus and rheumatoid arthritis. It is also known as an inhibitor of autophagy, a pro-survival mechanism utilized by many cancers. Evidence indicates that inhibition of autophagy can increase the therapeutic activity of ABC294640 in CCA. In Part 1 of this study, ABC294640 will be continuously administrated orally, twice a day, in 28 day cycles. In Part 2, ABC294640 and HCQ will be continuously administrated orally (the safe and tolerable will be determined in the study) in 28 day cycles. Administration of drug/s in both parts of the study will continue until disease progression, unacceptable toxicity or voluntary withdrawal initiated by the participants or physician.
NCT02942381 ↗	A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy	Completed	Peking University First Hospital	Phase 2	2016-09-13	The investigators study will recruit IgA nephropathy patients with proteinuria range from 0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB. The patients were treated with Hydroxychloroquine 200-400mg/d according to eGFR. The proteinuria will recorded every two months and total four months. Then, the drug will be stopped for two months for observation of change of proteinuria.
NCT02765594 ↗	Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy	Unknown status	Peking Union Medical College Hospital	Phase 4	2016-06-01	Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis in the world.There is to date no curative therapy for patients with IgAN.It is considered that dendritic cells, Toll-like receptor (TLR) 9 and cytokines interleukin-6 (IL-6), and interferon-alpha (IFN-a) and tumor necrosis factor-alpha (TNF-α), play an important role in the aberrant mucosal response. Hydroxychloroquine is an antimalarial agent and had a notable impact on immune activation by the reduction of circulating activated immune cells that including decreased TLR-expressing cells, reduced IFN-secreting plasmacytoid dendritic cells, reduced production of inflammatory cytokines including interferon alpha, IL-6 and TNF alpha. Recent studies showed hydroxychloroquine had a benefit for renal remission and could retard the onset of renal damage in patients with lupus nephritis. hydroxychloroquine may have the potential effect in IgA nephropathy, alleviated the proteinuria and had the renal protect effect. This will be a single center, prospective, randomized, controlled study to assess the utility of hydroxychloroquine in IgAN patients.
NCT02615938 ↗	Hydroxychloroquin (HCQ) in Pediatric Interstitial Lung Disease (ILD)	Suspended	Matthias Griese	Phase 2	2015-04-01	This is an exploratory Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multinational study investigating the initiation or withdrawal of hydroxychloroquine in subjects with chILD.
NCT02351752 ↗	Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study	Completed	LLiu	Phase 4	2015-01-01	IgA nephropathy is the most common type of primary glomerulonephritis and might caused by deposition of immune complex containing IgA in mesangium and causing local immune activation. Hydroxychloroquine reduces the activation of dendritic cells and the inflammatory process and showed the potential effect of treatment of patients with IgA nephropathy. The investigators study will recruite IgA nephropathy patients with proteinuria range from 0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB. The patients were treated with Hydroxychloroquine 300-400mg/d according to eGFR. The proteinuria will recorded every two months and total four months. Then, the drug will be stopped for two months for observation of change of proteinuria.
NCT01551069 ↗	Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion	Completed	Sanofi	Phase 3	2012-03-01	Primary Objective: - To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) with active skin manifestation (CLASI [Cutaneous Lupus Erythematosus Disease Area and Severity Index] activity score is ≥4) concomitant treatment with or without corticosteroid. Secondary Objectives: - To evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of once daily regiment of HCQ versus placebo as the reference group in patients with CLE and SLE with active skin manifestation (CLASI activity score is ≥4) concomitant treatment with or without corticosteroid. - To investigate the safety of 16 weeks treatment of once daily regiment of HCQ in patients with CLE and SLE with active skin manifestation concomitant treatment with or without corticosteroid. - To investigate the safety and efficacy of 52 weeks long-term treatment of once daily regimen of HCQ in patients with CLE and SLE - To investigate the influence of the dose reduction of corticosteroid on CLE and SLE patients treated with HCQ concomitant with corticosteroid - To investigate efficacy of once daily regimen of HCQ on systemic symptoms, musculoskeletal symptoms and immunological parameters in SLE patients.
NCT00946790 ↗	To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets	Completed	Sandoz	Phase 1	1993-07-01	To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.

Clinical Trial Conditions for HYDROXYCHLOROQUINE SULFATE

Condition Name

Condition Name for HYDROXYCHLOROQUINE SULFATE
Intervention	Trials
COVID-19	13
Covid19	4
Hydroxychloroquine	3
SARS-CoV-2	3

Condition MeSH

Condition MeSH for HYDROXYCHLOROQUINE SULFATE
Intervention	Trials
COVID-19	29
Coronavirus Infections	9
Severe Acute Respiratory Syndrome	7
Infection	5

Clinical Trial Locations for HYDROXYCHLOROQUINE SULFATE

Trials by Country

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−

Trials by Country for HYDROXYCHLOROQUINE SULFATE
Location	Trials
United States	29
Germany	8
China	6
Brazil	3
Thailand	3

Trials by US State

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−

Trials by US State for HYDROXYCHLOROQUINE SULFATE
Location	Trials
New York	4
New Jersey	3
Massachusetts	3
Pennsylvania	2
Washington	2

Clinical Trial Progress for HYDROXYCHLOROQUINE SULFATE

Clinical Trial Phase

Clinical Trial Phase for HYDROXYCHLOROQUINE SULFATE
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	9
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for HYDROXYCHLOROQUINE SULFATE
Clinical Trial Phase	Trials
Completed	13
Recruiting	12
Active, not recruiting	5

Clinical Trial Sponsors for HYDROXYCHLOROQUINE SULFATE

Sponsor Name

Sponsor Name for HYDROXYCHLOROQUINE SULFATE
Sponsor	Trials
Rutgers, The State University of New Jersey	3
Bill and Melinda Gates Foundation	2
University of Washington	2

Sponsor Type

Sponsor Type for HYDROXYCHLOROQUINE SULFATE
Sponsor	Trials
Other	97
Industry	10
U.S. Fed	1

Hydroxychloroquine Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction

Hydroxychloroquine sulfate, commonly known by its brand name Plaquenil, has been a subject of intense interest and debate, particularly since the onset of the COVID-19 pandemic. Originally used to treat malaria, rheumatoid arthritis, and autoimmune diseases like lupus, its potential as a therapeutic agent against COVID-19 has been extensively explored. Here, we delve into the current state of clinical trials, market analysis, and future projections for hydroxychloroquine sulfate.

Clinical Trials Update

Overview of Trials

Several clinical trials have been conducted or are ongoing to evaluate the efficacy and safety of hydroxychloroquine sulfate in treating COVID-19. These trials include various designs such as postexposure prophylaxis (PEP), preemptive early treatment (PET), and pre-exposure prophylaxis (PREP)[4].

Safety and Efficacy

Randomized, double-blind, placebo-controlled trials have been crucial in assessing the safety and efficacy of hydroxychloroquine. For instance, trials conducted in outpatient settings have shown that hydroxychloroquine can be safely administered, but its efficacy in preventing or treating COVID-19 remains under scrutiny. There is a call for additional large-scale randomized controlled trials to provide conclusive evidence on its clinical benefits and risks[1][4].

Dosing Regimens

Studies have proposed specific dosing regimens for hydroxychloroquine in treating SARS-CoV-2 infections. A recommended regimen includes a loading dose of 400 mg twice daily, followed by a maintenance dose of 200 mg twice daily for 4 days. This regimen is based on pharmacokinetic models that suggest hydroxychloroquine achieves higher lung concentrations compared to chloroquine, potentially enhancing its antiviral efficacy[3].

Market Analysis

Market Size and Growth

The hydroxychloroquine market has experienced significant growth, driven by several factors. In 2019, the market size was estimated to be $513.45 million, with a projected Compound Annual Growth Rate (CAGR) of 42.3% during the 2020-2025 period. More recent projections indicate a CAGR of 33.47%, reaching a market value of $5,415.23 million by 2026[2][5].

Segmentation

The market is segmented based on dosage type, application, and distribution channel. Key applications include malaria, rheumatoid arthritis, chronic discoid lupus erythematosus, and COVID-19 treatment. The Asia-Pacific region, particularly India and China, dominates the market due to high prevalence of malaria and other chronic diseases, as well as significant production and supply capacities[2][5].

Drivers of Growth

• Increasing Prevalence of Malaria and Autoimmune Diseases: The rising incidence of these conditions in both developed and developing countries has increased the demand for hydroxychloroquine.
• COVID-19 Pandemic: The emergency use authorization for hydroxychloroquine in treating COVID-19 has significantly boosted its demand globally[2][5].

Challenges

Despite the growth, the market faces challenges such as:

• Side Effects: Concerns over side effects like QTc prolongation and cardiac arrhythmias have raised safety concerns.
• Supply Shortages: Sudden surges in demand, particularly during the COVID-19 pandemic, have led to supply shortages.
• Stringent Regulations: Government regulations and the need for further clinical evidence to support widespread use also pose hurdles[2][5].

Market Projections

Future Growth Opportunities

The hydroxychloroquine market is expected to continue growing, driven by:

• Emerging Markets: Expansion into emerging markets offers significant opportunities for growth.
• Research and Development: Ongoing research into new formulations and applications of hydroxychloroquine could further enhance its market potential.
• Partnerships and Collaborations: Collaborations with healthcare organizations and government initiatives to combat diseases like malaria and COVID-19 can drive market expansion[5].

Geographical Dominance

The Asia-Pacific region, particularly India and China, is expected to continue dominating the market due to their large production capacities and high demand for the drug[2][5].

Distribution Channels

Online pharmacies, specialty drug stores, hospital pharmacies, and retail pharmacies are key distribution channels. The ease of oral administration and the flexibility in dosage have made oral administration the dominant segment in the market[2].

Safety Concerns and Regulatory Environment

Side Effects

Hydroxychloroquine is associated with several side effects, including QTc prolongation and cardiac arrhythmias, which have raised concerns about its safety profile. These concerns necessitate careful monitoring and further research to ensure safe use[1][3].

Regulatory Environment

The U.S. Food and Drug Administration (FDA) has approved emergency use of hydroxychloroquine for COVID-19 treatment, but its long-term use and widespread adoption await more robust clinical evidence. Stringent regulations and the need for additional randomized controlled trials are critical in shaping the regulatory environment for hydroxychloroquine[2][4].

Key Takeaways

• Clinical Trials: Ongoing and planned trials are crucial for determining the efficacy and safety of hydroxychloroquine in treating COVID-19.
• Market Growth: The market is expected to grow significantly, driven by increasing disease prevalence and the drug’s potential against COVID-19.
• Challenges: Side effects, supply shortages, and regulatory hurdles need to be addressed.
• Future Opportunities: Expansion into emerging markets, research into new formulations, and partnerships with healthcare organizations offer avenues for growth.

FAQs

What are the primary uses of hydroxychloroquine sulfate?

Hydroxychloroquine sulfate is primarily used to treat malaria, rheumatoid arthritis, and autoimmune diseases like lupus. It has also been explored as a potential treatment for COVID-19.

What are the key drivers of the hydroxychloroquine market?

The market is driven by the increasing prevalence of malaria and autoimmune diseases, as well as the drug’s potential effectiveness against COVID-19.

What are the main challenges facing the hydroxychloroquine market?

The market faces challenges such as side effects, supply shortages, and stringent government regulations.

Which region dominates the hydroxychloroquine market?

The Asia-Pacific region, particularly India and China, dominates the market due to high disease prevalence and significant production capacities.

What is the projected market size of hydroxychloroquine by 2026?

The market is projected to reach a value of $5,415.23 million by 2026, growing at a CAGR of 33.47%.

What are the recommended dosing regimens for hydroxychloroquine in treating COVID-19?

A recommended regimen includes a loading dose of 400 mg twice daily, followed by a maintenance dose of 200 mg twice daily for 4 days.

Sources

1. Hydroxychloroquine and Chloroquine for Treatment of SARS-CoV-2 - Academic.oup.com
2. Hydroxychloroquine Market 2020 - 2025 - IndustryARC
3. In Vitro Antiviral Activity and Projection of Optimized Dosing Design - Academic.oup.com
4. Safety of Hydroxychloroquine Among Outpatient Clinical Trial - Academic.oup.com
5. Hydroxychloroquine Market Key Players, Growth Analysis during - Taiwan News