CLINICAL TRIALS PROFILE FOR THIOGUANINE

All Clinical Trials for thioguanine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002590 ↗	Combination Chemotherapy in Treating Children With Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1994-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.
NCT00002590 ↗	Combination Chemotherapy in Treating Children With Lymphoma	Completed	Children's Oncology Group	Phase 2	1994-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.
NCT00002514 ↗	Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission	Completed	Medical Research Council	Phase 3	1993-04-01	RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.
NCT00002514 ↗	Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission	Completed	National Cancer Institute (NCI)	Phase 3	1993-04-01	RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.
NCT00002514 ↗	Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission	Completed	Eastern Cooperative Oncology Group	Phase 3	1993-04-01	RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.
NCT00002517 ↗	Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1993-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute myeloid leukemia or myelodysplastic syndrome. PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have newly diagnosed acute myeloid leukemia or myelodysplastic syndrome.
NCT00002531 ↗	Combination Chemotherapy in Treating Adults With Acute Lymphocytic Leukemia	Unknown status	Johann Wolfgang Goethe University Hospital	Phase 2	1993-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Randomized phase II trial to study the effectiveness of various combination chemotherapy regimens in treating patients with acute lymphocytic leukemia.

Clinical Trial Conditions for thioguanine

Condition Name

Condition Name for thioguanine
Intervention	Trials
Leukemia	36
Acute Lymphoblastic Leukemia	12
Untreated Childhood Acute Lymphoblastic Leukemia	9
B Acute Lymphoblastic Leukemia	8

Condition MeSH

Condition MeSH for thioguanine
Intervention	Trials
Leukemia	71
Precursor Cell Lymphoblastic Leukemia-Lymphoma	64
Leukemia, Lymphoid	58
Lymphoma	17

Clinical Trial Locations for thioguanine

Trials by Country

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Trials by Country for thioguanine
Location	Trials
Canada	166
Australia	83
New Zealand	25
Switzerland	18
Germany	17

Trials by US State

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−

Trials by US State for thioguanine
Location	Trials
California	42
Illinois	40
New York	40
Texas	39
Michigan	38

Clinical Trial Progress for thioguanine

Clinical Trial Phase

Clinical Trial Phase for thioguanine
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	49
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for thioguanine
Clinical Trial Phase	Trials
Completed	47
Recruiting	14
Active, not recruiting	12

Clinical Trial Sponsors for thioguanine

Sponsor Name

Sponsor Name for thioguanine
Sponsor	Trials
National Cancer Institute (NCI)	41
Children's Oncology Group	26
Johann Wolfgang Goethe University Hospital	5

Sponsor Type

Sponsor Type for thioguanine
Sponsor	Trials
Other	122
NIH	43
Industry	14

Thioguanine: Clinical Trials, Market Analysis, and Projections

Introduction to Thioguanine

Thioguanine, an antimetabolite medication, is primarily used in the treatment of various types of leukemia, including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). It functions by inhibiting the synthesis and function of DNA and RNA, thereby arresting the growth of cancer cells[2][3][5].

Clinical Trials Update

The TEAM Study

One significant clinical trial involving thioguanine is the TEAM Study (Thiopurine EnhAnced Maintenance therapy). This Phase 1-2 study aims to explore the feasibility of using 6-thioguanine (6TG) as a supplement to the standard maintenance therapy of ALL and lymphoblastic non-Hodgkin’s lymphoma. The trial combines 6TG with methotrexate (MTX) and 6-mercaptopurine (6MP) to assess whether this combination can achieve higher DNA-thioguanine nucleotide (TGN) levels and enhance the effect of 6MP. The study also focuses on describing toxicities, hematology, and thiopurine metabolite levels during this combination therapy[1].

Safety and Toxicity Monitoring

In the TEAM Study, the frequency of controls was increased to monitor any toxicities early, especially myelo- or hepatotoxicity. The dosing of 6MP and MTX was adjusted according to the NOPHO therapy guidelines in case of such toxicities. The administration of 6TG was either withheld or reduced depending on the severity of the toxicity[1].

Thioguanine in Inflammatory Bowel Disease

Another area of clinical research involves the use of thioguanine in the treatment of inflammatory bowel disease (IBD). A retrospective cohort study examined the safety, effectiveness, and 12-month drug survival of thioguanine in thiopurine-naïve patients with IBD. The study found that thioguanine was clinically effective in 53% of patients at 12 months, with an acceptable safety profile and a low cessation rate due to adverse events. This suggests that thioguanine could potentially be used as a first-line maintenance therapy for IBD instead of conventional thiopurines[4].

Market Analysis

Current Market Size and Growth

The 6-thioguanine market has shown steady growth, valued at USD 49.58 million in 2023 and expected to reach USD 52.11 million in 2024. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.15%, reaching USD 70.51 million by 2030[2][5].

Market Drivers

Several factors drive the growth of the 6-thioguanine market:

• Increasing Prevalence of Leukemia: The rising incidence of chronic myeloid leukemia and other cancers increases the demand for effective treatments like 6-thioguanine[2][5].
• Advances in Cancer Research: Growing investments by pharmaceutical companies in oncology research contribute to market growth by enhancing the efficacy and safety of 6-thioguanine[2][5].
• Rising Healthcare Expenditure: Increased healthcare spending and focused government initiatives towards cancer care further support market growth[2][5].

Market Restraints

Despite the growth, the market faces several challenges:

• Strict Regulatory Approval Processes: The stringent regulatory frameworks for drug approval can slow down market expansion[2][5].
• Potential Side Effects: Severe side effects such as liver dysfunction and myelosuppression can deter broader adoption of 6-thioguanine[2][5].
• Competition from Alternative Treatments: The presence of alternative treatments and the proliferation of generic medicines due to patent expirations pose significant competition[2][5].

Market Opportunities

There are several opportunities for growth and innovation in the 6-thioguanine market:

• Expanding Applications: Research into using 6-thioguanine beyond leukemia, such as in IBD, can expand its market scope[4][5].
• Combination Therapies: Understanding the potential of 6-thioguanine in combination therapies can enhance its efficacy and market appeal[1][5].
• Emerging Markets: Targeting emerging markets in Asia-Pacific and Latin America, where healthcare infrastructure is improving, presents significant growth opportunities[5].

Strategic Recommendations

To succeed in the 6-thioguanine market, companies should:

• Focus on Personalized Medicine: Research involving pharmacogenomics to tailor 6-thioguanine treatments according to genetic profiles can reduce adverse effects and enhance effectiveness[5].
• Optimize Dosage Regimens: Developing novel dosage regimens and delivery mechanisms can provide competitive advantages[5].
• Collaborate with Biotech Firms: Partnerships with research institutions and biotech firms can help in exploring new formulations or delivery systems[2][5].

Key Players in the Market

The 6-thioguanine market is characterized by the presence of several key players, including:

• Amgen Inc.
• Aspen Pharmacare
• Celgene Corporation
• Eli Lilly and Company
• Fresenius Kabi
• GlaxoSmithKline plc
• Merck & Co., Inc.
• Mylan N.V.
• Pfizer Inc.
• Taj Pharmaceuticals Ltd.
• Zydus Cadila[2][5].

Market Segmentation and Coverage

The market is segmented based on treatment type, dosage form, indication, and distribution channels. The primary indications include acute lymphoblastic leukemia and acute myeloid leukemia, with applications in hospital pharmacies, cancer treatment centers, and specialty clinics[2][5].

Conclusion

Thioguanine remains a critical component in the treatment of leukemia and is being explored for its potential in other conditions like IBD. The market for 6-thioguanine is expected to grow steadily, driven by increasing cancer incidence and advancements in cancer research. However, it faces challenges such as strict regulatory processes and potential side effects. By focusing on personalized medicine, optimizing dosage regimens, and collaborating with biotech firms, companies can navigate these challenges and capitalize on the growing demand for 6-thioguanine.

Key Takeaways

• Clinical Trials: The TEAM Study and other trials are exploring the efficacy and safety of 6-thioguanine in combination therapies and new indications.
• Market Growth: The 6-thioguanine market is projected to grow at a CAGR of 5.15%, reaching USD 70.51 million by 2030.
• Market Drivers: Increasing prevalence of leukemia, advances in cancer research, and rising healthcare expenditure drive market growth.
• Market Restraints: Strict regulatory processes, potential side effects, and competition from alternative treatments are significant challenges.
• Market Opportunities: Expanding applications, combination therapies, and targeting emerging markets offer growth opportunities.

FAQs

What is the primary use of thioguanine?

Thioguanine is primarily used as a chemotherapy drug to treat acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML)[2][3][5].

What are the potential side effects of thioguanine?

Thioguanine can cause severe side effects such as liver dysfunction and myelosuppression, which can deter broader adoption[2][5].

What is the current market size of 6-thioguanine?

The 6-thioguanine market was valued at USD 49.58 million in 2023 and is expected to reach USD 52.11 million in 2024[2][5].

What are the key drivers of the 6-thioguanine market?

The key drivers include the increasing prevalence of leukemia, advances in cancer research, and rising healthcare expenditure[2][5].

Which companies are key players in the 6-thioguanine market?

Key players include Amgen Inc., Aspen Pharmacare, Celgene Corporation, Eli Lilly and Company, and others[2][5].

Sources

1. Clinical Trials Register EU: EudraCT Number 2014-002248-42 - Clinical trial results.
2. Research and Markets: 6-Thioguanine Market by Treatment Type, Dosage Form, Indication ...
3. National Cancer Institute: Thioguanine - NCI.
4. Oxford Academic: Effectiveness and Safety of First-Line Thioguanine in Thiopurine ...
5. GII Research: 6-Thioguanine Market by Treatment Type, Dosage Form, Indication ...