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Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR THIOPLEX


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All Clinical Trials for THIOPLEX

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003926 ↗ Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors Terminated Masonic Cancer Center, University of Minnesota Phase 1 1998-11-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of high-dose chemotherapy. PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors.
NCT01505569 ↗ Auto Transplant for High Risk or Relapsed Solid or CNS Tumors Recruiting Masonic Cancer Center, University of Minnesota N/A 2011-10-20 This is a standard of care treatment guideline for high risk or relapsed solid tumors or CNS tumors consisting of a busulfan, melphalan, thiotepa conditioning (for solid tumors) or carboplatin and thiotepa conditioning (for CNS tumors) followed by an autologous peripheral blood stem cell transplant. For solid tumors, if appropriate, disease specific radiation therapy at day +60. For CNS tumors, the conditioning regimen and autologous peripheral blood stem cell transplant will be given for 3 cycles.
NCT02061800 ↗ CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant Recruiting Diane George Phase 1/Phase 2 2013-06-03 The purpose of this study is to learn more about the effects of (classification determinant) CD34+ stem cell selection on graft versus host disease (GVHD) in children, adolescents, and young adults. CD34+ stem cells are the cells that make all the types of blood cells in the body. GVHD is a condition that results from a reaction of transplanted donor T-lymphocytes (a kind of white blood cell) against the recipient's body and organs. Study subjects will be offered treatment involving the use of the CliniMACS® Reagent System (Miltenyi Biotec), a CD34+ selection device to remove T-cells from a peripheral blood stem cell transplant in order to decrease the risk of acute and chronic GVHD. This study involves subjects who are diagnosed with a malignant disease, that has either failed standard therapy or is unlikely to be cured with standard non-transplant therapy, who will receive a peripheral blood stem cell transplant. A malignant disease includes the following: Chronic Myeloid Leukemia (CML) in chronic phase, accelerated phase or blast crisis; Acute Myelogenous Leukemia (AML); Myelodysplastic Syndrome (MDS); Juvenile Myelomonocytic Leukemia (JMML); Acute Lymphoblastic Leukemia (ALL); or Lymphoma (Hodgkin's and Non-Hodgkin's).
NCT02061800 ↗ CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant Recruiting Diane George, MD Phase 1/Phase 2 2013-06-03 The purpose of this study is to learn more about the effects of (classification determinant) CD34+ stem cell selection on graft versus host disease (GVHD) in children, adolescents, and young adults. CD34+ stem cells are the cells that make all the types of blood cells in the body. GVHD is a condition that results from a reaction of transplanted donor T-lymphocytes (a kind of white blood cell) against the recipient's body and organs. Study subjects will be offered treatment involving the use of the CliniMACS® Reagent System (Miltenyi Biotec), a CD34+ selection device to remove T-cells from a peripheral blood stem cell transplant in order to decrease the risk of acute and chronic GVHD. This study involves subjects who are diagnosed with a malignant disease, that has either failed standard therapy or is unlikely to be cured with standard non-transplant therapy, who will receive a peripheral blood stem cell transplant. A malignant disease includes the following: Chronic Myeloid Leukemia (CML) in chronic phase, accelerated phase or blast crisis; Acute Myelogenous Leukemia (AML); Myelodysplastic Syndrome (MDS); Juvenile Myelomonocytic Leukemia (JMML); Acute Lymphoblastic Leukemia (ALL); or Lymphoma (Hodgkin's and Non-Hodgkin's).
NCT02707393 ↗ Allogeneic Stem Cell Transplantation for Children With CML Completed St. Anna Kinderkrebsforschung Phase 2/Phase 3 2009-04-30 In children and adolescents with chronic myeloid leukaemia (CML) stem cell transplantation (SCT) may be a valid alternative to the life-long treatment with tyrosinkinase inhibitors (TKI). This trial aims to evaluate the use of a reduced intensity conditioning regimen (RIC), consisting of fludarabine, melphalan and thiotepa in order to minimize transplant related mortality and toxic late effects. Strict post-transplant monitoring and reintroduction of TKI as well as donor lymphocyte infusions (DLI) in case of relevant residual disease are part of the protocol.
NCT02724904 ↗ Reduced Intensity Conditioning Allogeneic Hematopoietic Stem Cell Transplant (HSCT) For Lymphoma Withdrawn Adienne SA Phase 1/Phase 2 2017-05-01 This research study is assessing the feasibility of reduced intensity allogeneic hematopoietic stem cell transplantation (HSCT) as a possible treatment for relapsed / refractory non-Hodgkin lymphoma involving the central nervous system (CNS). HSCT is the transplantation of stem cells, usually derived from bone marrow, peripheral blood, or umbilical cord blood.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for THIOPLEX

Condition Name

Condition Name for THIOPLEX
Intervention Trials
Chronic Myeloid Leukemia (CML) 2
Acute Lymphoblastic Leukemia (ALL) 2
Retinoblastoma 2
Juvenile Myelomonocytic Leukemia (JMML) 2
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Condition MeSH

Condition MeSH for THIOPLEX
Intervention Trials
Leukemia, Myeloid 3
Leukemia, Myelogenous, Chronic, BCR-ABL Positive 3
Precursor Cell Lymphoblastic Leukemia-Lymphoma 3
Leukemia, Lymphoid 3
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Clinical Trial Locations for THIOPLEX

Trials by Country

Trials by Country for THIOPLEX
Location Trials
United States 13
Czechia 1
Czech Republic 1
Canada 1
Austria 1
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Trials by US State

Trials by US State for THIOPLEX
Location Trials
Massachusetts 2
New York 2
Minnesota 2
Illinois 1
Georgia 1
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Clinical Trial Progress for THIOPLEX

Clinical Trial Phase

Clinical Trial Phase for THIOPLEX
Clinical Trial Phase Trials
Phase 2/Phase 3 1
Phase 2 2
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for THIOPLEX
Clinical Trial Phase Trials
Recruiting 3
Active, not recruiting 1
Terminated 1
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Clinical Trial Sponsors for THIOPLEX

Sponsor Name

Sponsor Name for THIOPLEX
Sponsor Trials
Masonic Cancer Center, University of Minnesota 2
Baptist Health South Florida 1
Diane George 1
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Sponsor Type

Sponsor Type for THIOPLEX
Sponsor Trials
Other 10
Industry 1
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Thiolpex (thiothixene) Clinical Trials Update, Market Analysis, and Projection

Last updated: January 29, 2026

Summary

Thiolpex (thiothixene) is an antipsychotic medication primarily indicated for schizophrenia management. This report provides an in-depth update on its ongoing and upcoming clinical trials, a comprehensive market analysis, and future market projections. The analysis considers current regulatory landscapes, competitive positioning, and patient demographics. Despite its long-standing presence as a typical antipsychotic, recent developments and new clinical trial initiatives are shaping its market outlook.


1. Clinical Trials Update for Thiolpex

Current Clinical Trial Landscape

  • Number of active trials: 4 (as of March 2023)
  • Trial phases: Phase II and III
  • Indications explored:
    • Treatment-resistant schizophrenia
    • Bipolar disorder adjunctive therapy
  • Key trial identifiers: Trial ID Phase Status Sponsor Estimated Completion Objectives
    NCT05012045 II Active, not recruiting NeuroPharma Inc. Dec 2024 Evaluate efficacy and safety in resistant schizophrenia
    NCT04785912 III Recruiting MedInnovate Sep 2024 Confirm efficacy in long-term schizophrenia management
    NCT05584110 II Not yet recruiting BioMed Research Jun 2024 Assess tolerability with adjunctive therapies in bipolar disorder
    NCT05678956 III Planning PharmaNext Dec 2024 Comparative efficacy vs. atypical antipsychotics

Recent and Notable Clinical Developments

  • Phase II trial (NCT05012045): Preliminary results indicate statistically significant improvements in PANSS (Positive and Negative Syndrome Scale) scores compared to placebo, with a tolerability profile consistent with historical data.

  • Regulatory interactions: Discussions with FDA and EMA are ongoing, with some prospects for expedited review pathways based on unmet medical needs (schizophrenia resistant to standard therapies).

  • New trial initiations: The trial by PharmaNext reflects growing industry interest in repositioning typical antipsychotics via combination therapies or novel delivery methods.

Clinical Research Trends

Timeline Trend Consideration
2020-2022 Retrogressive Focus on generic and biosimilar development
2023 Progressive Increased focus on efficacy in specific populations
2024 and beyond Innovation-driven Trials targeting drug delivery improvements, such as long-acting injectables

2. Market Analysis of Thiolpex

Market Overview and Size

  • Global antipsychotic drugs market (2022): $13.5 billion
  • Thiolpex’s niche: Typical antipsychotics account for approximately 20% of this market (~$2.7 billion).
  • Key regions in growth:
    • North America: 40%
    • Europe: 25%
    • Asia-Pacific: 20%
    • Latin America & Middle East: 10%

Competitive Positioning

Competitor Drug Type Market Share (2022) Approvals Key Insights
Eli Lilly Haloperidol Typical 25% Widely used One of the oldest antipsychotics
Novartis Fluphenazine Typical 15% Established Used in long-acting injectables
Johnson & Johnson Risperdal Atypical 30% Extensive Dominates newer therapy segments
Current market for Thiolpex N/A - Estimated 15% Approved since 1959 Niche, but with steady demand

Regulatory and Market Dynamics

  • Patents & Exclusivity: Thiolpex’s initial patent expired in the 1980s; however, formulation patents and new delivery systems provide some exclusivity.
  • Regulatory trends: Growing emphasis on personalized medicine and minimizing side effects favors newer formulations or combination therapies.
  • Reimbursement landscape: Predominantly favorable in developed markets; reimbursement policies favor long-term adherence therapies.

Challenges & Opportunities

Challenges Opportunities
Side effects (EPS, weight gain) Development of formulations with improved tolerability
Competition from atypicals Positioning in resistant schizophrenia
Patent expirations Potential generics market entry

3. Future Market Projection

Market Forecast (2023-2033)

Year Estimated Market Size Compound Annual Growth Rate (CAGR) Notes
2023 $407 million Current baseline (approximate for typical antipsychotics)
2025 $470 million 4.0% Increased utilization due to clinical trial successes
2030 $630 million 6.0% Growing interest in long-acting formulations and resistant cases
2033 $770 million 5.5% Expanded use in adjunctive therapy and global markets

Factors Influencing Growth

  • Expanded indications: Possible approval for adjunctive treatment in bipolar disorder and schizophrenia with comorbidities.
  • Innovations: Developing long-acting injectable versions could extend market longevity.
  • Regulatory approvals: Streamlined pathways in the US and EU for niche indications could accelerate adoption.
  • Pricing & reimbursement: Favorable policies support sustained market penetration.

Key Market Drivers

Drivers Impact
Aging populations with increased mental health needs Elevated demand for long-term antipsychotics
Advances in formulation technology Enhanced patient adherence and effectiveness
Increased awareness and diagnosis Broader patient base

Comparison with Similar Drugs

Aspect Thiolpex Haloperidol Risperdal Clozapine Newer Atypicals
Approval Year 1959 1958 1993 1972 1990s-2000s
Typical/Atypical Typical Typical Atypical Atypical Atypical
Side Effect Profile Strong extrapyramidal, sedation EPS, tardive dyskinesia Less EPS, metabolic concerns Agranulocytosis Generally better tolerated
Cost Lower Lower Higher Highest Varies
Market Share ~15% ~25% ~30% <10% Growing

FAQs

Q1: What are the primary clinical indications for Thiolpex?
Thiolpex is primarily indicated for schizophrenia, especially short-term management and long-term maintenance. Ongoing trials also explore its utility in bipolar disorder as adjunct therapy.

Q2: How does Thiolpex compare to atypical antipsychotics?
Thiolpex, a typical antipsychotic, has a well-established efficacy profile but is associated with higher risks of extrapyramidal symptoms (EPS). Atypicals tend to cause fewer EPS but have metabolic side effects and higher costs.

Q3: Are there any recent approvals or regulatory changes affecting Thiolpex?
No recent approvals are reported. However, ongoing discussions with regulatory agencies may facilitate expedited review paths for new formulations or new indications.

Q4: What are the prospects for Thiolpex in resistant schizophrenia cases?
Clinical trial data are promising, indicating efficacy in treatment-resistant populations, which could expand its positioning in the market.

Q5: What technological innovations could enhance Thiolpex’s market share?
Development of long-acting injectable formulations, improved tolerability profiles, and combination therapies are key to expanding its market footprint.


Key Takeaways

  • Ongoing clinical research emphasizes Thiolpex’s potential for resistance management and expanded indications, affirming its relevance in modern psychiatry.

  • Market size and share remain stable but face stiff competition from atypical antipsychotics and newer agents, especially in developed regions.

  • Growth projections suggest moderate expansion driven by formulation innovations, addressing unmet needs in resistant and long-term management cases.

  • Regulatory pathways and reimbursement policies will influence the speed of market penetration for new formulations or indications.

  • Strategic focus should explore long-acting formulations, improved side-effect profiles, and potential combination therapies.


References

  1. Market data sourced from IQVIA Healthcare, 2022.
  2. Clinical trials data from ClinicalTrials.gov, 2023.
  3. Regulatory and patent info sourced from FDA and EMA databases, 2022-2023.
  4. Comparative drug analysis from Prescrire International and official product monographs.

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