CLINICAL TRIALS PROFILE FOR ALLOPURINOL

All Clinical Trials for ALLOPURINOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000658 ↗	A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma	Completed	Schering-Plough	Phase 3	1969-12-31	To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
NCT00000658 ↗	A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
NCT00000703 ↗	Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To determine the safety and effectiveness of a combination chemotherapy-radiation-zidovudine (AZT) treatment for patients with peripheral lymphoma. Other chemotherapies have been tried in patients with AIDS related lymphomas, but the results have not been satisfactory. This study will show whether the combination of chemotherapy, radiation, and AZT is more effective and less toxic than previously used treatments.

Clinical Trial Conditions for ALLOPURINOL

Condition Name

Condition Name for ALLOPURINOL
Intervention	Trials
Gout	46
Hyperuricemia	21
Leukemia	18

Condition MeSH

Condition MeSH for ALLOPURINOL
Intervention	Trials
Gout	46
Leukemia	32
Hyperuricemia	30

Clinical Trial Locations for ALLOPURINOL

Trials by Country

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Trials by Country for ALLOPURINOL
Location	Trials
United States	823
Canada	55
Australia	23
United Kingdom	21
Poland	20

Trials by US State

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Trials by US State for ALLOPURINOL
Location	Trials
Texas	57
California	40
North Carolina	31
Florida	30
New York	29

Clinical Trial Progress for ALLOPURINOL

Clinical Trial Phase

Clinical Trial Phase for ALLOPURINOL
Clinical Trial Phase	Trials
Phase 4	42
Phase 3	45
Phase 2/Phase 3	12

Clinical Trial Status

Clinical Trial Status for ALLOPURINOL
Clinical Trial Phase	Trials
Completed	129
Recruiting	22
Terminated	20

Clinical Trial Sponsors for ALLOPURINOL

Sponsor Name

Sponsor Name for ALLOPURINOL
Sponsor	Trials
M.D. Anderson Cancer Center	17
Ardea Biosciences, Inc.	14
AstraZeneca	9

Sponsor Type

Sponsor Type for ALLOPURINOL
Sponsor	Trials
Other	286
Industry	96
NIH	33

Allopurinol: Clinical Trials Update, Market Analysis, and Projections

Introduction to Allopurinol

Allopurinol is a widely used medication for treating gout and hyperuricemia by reducing uric acid production in the body. It is also utilized in managing kidney stones and in some cases, to lower uric acid levels in patients undergoing cancer treatment.

Current Clinical Trials

Tigulixostat vs. Allopurinol in Gout Patients

A significant ongoing clinical trial involves the comparison of Tigulixostat with Allopurinol in gout patients. This Phase 3 study, sponsored by LG Chem, is a randomized, multi-regional, double-blind, double-dummy parallel-group trial. The study aims to assess the efficacy and safety of Tigulixostat compared to Allopurinol and placebo in patients with gout and hyperuricemia.

• Study Details:
  • Start Date: March 30, 2023
  • Primary Completion Date: July 2025
  • Study Completion Date: December 2025
  • Participants: 2542
  • Outcome Measures: Serum uric acid levels, gout flare frequency, and tophus resolution[1].

Allopurinol in Chronic Kidney Disease

Another notable trial is the Phase 2b study conducted by AstraZeneca, which investigates the combination of Verinurad and Allopurinol in patients with chronic kidney disease and hyperuricemia. This multicenter, randomized, double-blind, placebo-controlled study aims to establish the optimal dose of Verinurad when combined with Allopurinol.

• Study Details:
  • Phase: 2b
  • Participants: 861
  • Interventions: Various doses of Verinurad and Allopurinol, including a placebo arm
  • Primary Purpose: Treatment of chronic kidney disease and hyperuricemia[4].

Allopurinol in Type 1 Diabetes

A Phase 3 clinical trial funded by the Juvenile Diabetes Research Foundation (JDRF) is examining whether Allopurinol can preserve kidney function in type 1 diabetic patients. This multicenter trial is part of the PERL (Preventing Early Renal Loss in Diabetes) study and aims to intervene early in kidney disease to prevent or reverse renal damage.

• Study Details:
  • Phase: 3
  • Participants: Initially 31 in the pilot study, with plans for a larger pivotal trial
  • Primary Purpose: To test whether Allopurinol can preserve kidney function[3].

Market Analysis and Projections

Global Market Trends

The global Allopurinol market is expected to experience significant growth from 2022 to 2029. Here are some key trends and projections:

• Market Growth Rate: The market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 6% during the forecast period[2].
• Drivers: The rise in incidences of gout and kidney stones, increasing geriatric population, rising healthcare expenditure, and growing demand from various end-use industries are major drivers for market growth[2].
• Challenges: High drug costs and side effects associated with Allopurinol, such as loss of appetite, dizziness, and skin rash, are expected to hamper market growth. Lack of awareness in some regions will also pose a challenge[2].

Market Segmentation

The Allopurinol market is segmented based on several factors:

• Drug Class: Antigout agents and antihyperuricemic agents.
• Application: Gout, kidney stones, and others.
• Demographic: Adult and pediatric.
• Dosage Form: Intravenous powder for injection and oral tablets.
• End-Users: Clinics, hospitals, and others.
• Distribution Channel: Hospital pharmacy, retail pharmacy, and online pharmacy[2].

Regional Analysis

• North America: Dominates the market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure.
• Asia-Pacific: Expected to grow significantly during the forecast period due to increasing research and development activities and growing government support[2].

Key Market Insights

Increasing Incidence of Gout and Kidney Stones

The global rise in gout and kidney stone cases is a significant factor driving the demand for Allopurinol. As the population ages and lifestyle factors contribute to higher uric acid levels, the need for effective treatments like Allopurinol is expected to increase[2].

Healthcare Expenditure and Awareness

Rising healthcare expenditure and increasing awareness about the importance of managing hyperuricemia are also boosting the market. However, the lack of awareness in some regions remains a challenge that needs to be addressed[2].

Competitive Landscape

The market is competitive, with several key players involved in the production and distribution of Allopurinol. Brand names like Zyloprim and Lopurin, as well as generic versions, are widely available. The entry of new players and the development of new markets are expected to provide beneficial opportunities for growth[2].

Future Outlook

Emerging Markets and R&D

Emerging markets, particularly in the Asia-Pacific region, are expected to contribute significantly to the growth of the Allopurinol market. Increased research and development activities, along with growing government support, will drive this growth. New market opportunities and the expansion of existing ones will further enhance the market's potential[2].

Technological Innovations

Technological innovations in drug delivery systems and the development of combination therapies, such as the Verinurad and Allopurinol combination, are likely to improve treatment outcomes and patient compliance. These advancements will play a crucial role in shaping the future of the Allopurinol market[4].

Key Takeaways

• Clinical Trials: Ongoing trials comparing Allopurinol with new treatments like Tigulixostat and combining it with Verinurad for chronic kidney disease management.
• Market Growth: Expected to grow at a CAGR of 6% from 2022 to 2029 driven by increasing gout and kidney stone cases, and rising healthcare expenditure.
• Regional Dominance: North America currently dominates the market, but Asia-Pacific is expected to grow significantly.
• Challenges: High drug costs and side effects are major challenges, while lack of awareness in some regions also hampers growth.
• Future Outlook: Emerging markets, R&D activities, and technological innovations will drive future growth.

FAQs

What is the primary use of Allopurinol?

Allopurinol is primarily used to treat gout and hyperuricemia by reducing uric acid production in the body. It is also used to manage kidney stones and lower uric acid levels in patients undergoing cancer treatment.

What are the common side effects of Allopurinol?

Common side effects of Allopurinol include loss of appetite, dizziness, fever, chills, blood in urine, and skin rash.

Which regions dominate the Allopurinol market?

North America currently dominates the Allopurinol market due to the presence of major key players and well-developed healthcare infrastructure. However, the Asia-Pacific region is expected to grow significantly during the forecast period.

What are the key drivers for the growth of the Allopurinol market?

The rise in incidences of gout and kidney stones, increasing geriatric population, rising healthcare expenditure, and growing demand from various end-use industries are major drivers for market growth.

Are there any ongoing clinical trials involving Allopurinol?

Yes, there are several ongoing clinical trials involving Allopurinol, including a Phase 3 study comparing Tigulixostat with Allopurinol in gout patients and a Phase 2b study combining Verinurad with Allopurinol for chronic kidney disease management.

Sources

1. ClinicalTrials.gov, "A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia," Retrieved October 2023.
2. Data Bridge Market Research, "Global Allopurinol Market - Industry Trends and Forecast to 2029," Retrieved 2023.
3. ClinicalTrials.gov, "A multicenter clinical trial of allopurinol to prevent GFR loss in type 1 diabetes," Retrieved February 1, 2014.
4. AstraZeneca Clinical Trials, "A Study of Verinurad and Allopurinol in Patients with Chronic Kidney Disease and Hyperuricaemia," Verified September 1, 2023.
5. 6Wresearch, "Palau Allopurinol Market (2024-2030) | Growth, Competitive Landscape," Retrieved 2023.