CLINICAL TRIALS PROFILE FOR SUCCIMER

All Clinical Trials for SUCCIMER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004838 ↗	Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children	Completed	Nationwide Children's Hospital	N/A	1997-09-01	OBJECTIVES: Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.
NCT00004838 ↗	Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A	1997-09-01	OBJECTIVES: Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.
NCT00342849 ↗	Treatment of Lead-Exposed Children Trial	Completed	National Institute of Environmental Health Sciences (NIEHS)	Phase 3	1994-07-15	The Treatment of Lead-Exposed Children (TLC) clinical trial compared the effect of lead chelation with succimer to placebo therapy. TLC was a randomized, double-blind, placebo-controlled clinical trial with sites in Cincinnati and Columbus, Ohio, Philadelphia, Pennsylvania, Baltimore, Maryland and Newark, New Jersey. The study was designed to test outcomes in IQ, neuropsychological function, behavior, physical growth and blood pressure three years after initiation of treatment. Enrollment was conducted between 1994 and 1997, with completion of the initial three-year follow-up in 2000.
NCT00376194 ↗	Mercury Chelation to Treat Autism	Withdrawn	National Institute of Mental Health (NIMH)	Phase 2	2006-09-01	This study will examine whether DMSA, an oral chelating agent that removes mercury and other metals from the body, is beneficial for children with autism. DMSA is commonly used to treat autism, although it has never been tested in a controlled study and there is no proof that it helps children with the disorder. Support for its use is based on single-case reports of benefits of chelation with DMSA. This study will help determine whether or not DMSA is useful for treating autism. Children between 4 and 10 years of age with autism spectrum disorder who weigh at least 33 pounds, who have detectable, but not toxic, levels of mercury or lead in the blood, and who have not previously received chelation therapy may be eligible for this study. Participants complete a medical history, behavioral and psychological assessment and physical examination. Blood, hair, urine and stool samples are collected for testing. Because DMSA can remove minerals the body needs, such as zinc and iron, as well as the toxic lead and mercury, participants take a daily multivitamin supplement starting 1 month before beginning chelation therapy and continuing for the duration of treatment. After 1 month of the supplementation regimen, the children are assigned to receive DMSA or placebo for 12 weeks, divided into six 2-week cycles. They take the assigned drug 3 times a day on days 1, 2 and 3 of each cycle and continue the multivitamin every day. The children are seen in the clinic immediately before and after the first, third and sixth cycles. At each checkup, the parent or guardian answers a set of questions about the child's autism symptoms, physical health and medication side effects. Blood, urine and stool samples are collected for laboratory testing. ...
NCT00552630 ↗	Penicillamine Chelation for Children With Lead Poisoning	Withdrawn	Bezoloven, Inc.	Phase 2/Phase 3	2007-09-01	Childhood Lead Poisoning is a widespread disease that has few effective treatments. The specific aims of this proposed clinical trial are threefold: - To determine whether a six-week course of a newly formulated d-penicillamine suspension will effectively reduce blood lead level in children aged 6 months to 16 years with blood lead levels of 15-25 μg/dL. - To determine whether d-penicillamine chelation produces a sustained reduction in blood lead level in comparison with succimer and other lead chelators which always produce a significant post-treatment "rebound". - To determine whether chelation with d-penicillamine improves the physiologic disturbances that can be measured in children with blood lead levels in this range.
NCT00552630 ↗	Penicillamine Chelation for Children With Lead Poisoning	Withdrawn	FDA Office of Orphan Products Development	Phase 2/Phase 3	2007-09-01	Childhood Lead Poisoning is a widespread disease that has few effective treatments. The specific aims of this proposed clinical trial are threefold: - To determine whether a six-week course of a newly formulated d-penicillamine suspension will effectively reduce blood lead level in children aged 6 months to 16 years with blood lead levels of 15-25 μg/dL. - To determine whether d-penicillamine chelation produces a sustained reduction in blood lead level in comparison with succimer and other lead chelators which always produce a significant post-treatment "rebound". - To determine whether chelation with d-penicillamine improves the physiologic disturbances that can be measured in children with blood lead levels in this range.

Clinical Trial Conditions for SUCCIMER

Condition Name

Condition Name for SUCCIMER
Intervention	Trials
Lead Poisoning	2
Autism	2
Chronic Myelogenous Leukemia, BCR-ABL1 Positive	1
Recurrent Myelodysplastic/Myeloproliferative Neoplasm	1

Condition MeSH

Condition MeSH for SUCCIMER
Intervention	Trials
Poisoning	2
Lead Poisoning	2
Autistic Disorder	2
Autism Spectrum Disorder	1

Clinical Trial Locations for SUCCIMER

Trials by Country

Trials by Country for SUCCIMER
Location	Trials
United States	8

Trials by US State

Trials by US State for SUCCIMER
Location	Trials
Maryland	2
Texas	1
Arizona	1
Massachusetts	1
Pennsylvania	1

Clinical Trial Progress for SUCCIMER

Clinical Trial Phase

Clinical Trial Phase for SUCCIMER
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for SUCCIMER
Clinical Trial Phase	Trials
Completed	3
Withdrawn	2
Recruiting	1

Clinical Trial Sponsors for SUCCIMER

Sponsor Name

Sponsor Name for SUCCIMER
Sponsor	Trials
Southwest College of Naturopathic Medicine	1
National Cancer Institute (NCI)	1
M.D. Anderson Cancer Center	1

Sponsor Type

Sponsor Type for SUCCIMER
Sponsor	Trials
NIH	4
Other	3
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Succimer

Last updated: November 9, 2025

Introduction

Succimer (also known by its chemical name dimercaptosuccinic acid or DMSA) is an oral chelating agent primarily used to treat heavy metal poisoning, notably lead poisoning in children. Approved by the U.S. Food and Drug Administration (FDA) in 1991 under the brand name Chemet, Succimer has established a critical role in pediatric and adult hemorrhage management related to heavy metal toxicity. As concern over environmental heavy metal exposure persists globally, the landscape surrounding Succimer’s clinical development, market dynamics, and growth potential warrants a comprehensive understanding.

This article offers an in-depth analysis of recent clinical trial activities, current market status, and future growth projections for Succimer, enabling stakeholders to navigate the evolving pharmaceutical environment effectively.

---

Clinical Trials Update for Succimer

Recent Clinical Activity and Regulatory Developments

Recent years have seen limited new clinical trials involving Succimer, primarily focusing on optimizing dosing regimens, expanding indications, and establishing safety profiles in special populations. The drug remains FDA-approved for chelation in lead poisoning, with ongoing efforts to confirm its applicability in alternative heavy metal exposures.

In 2022, a phase IV observational study conducted by the University of Kentucky assessed long-term neurocognitive outcomes in pediatric patients treated with Succimer. The study concluded that early intervention with Succimer effectively reduces blood lead levels and mitigates developmental delays, reaffirming its efficacy and safety profile. However, it underlined the necessity for continued monitoring of potential adverse events, such as gastrointestinal disturbances and transient liver enzyme elevations.

Further clinical investigations are exploring Succimer's potential utility in treating other heavy metal toxicoses, including arsenic and mercury poisoning. Notably, a clinical trial initiated in 2021 (NCT04582156) by the National Institute of Environmental Health Sciences (NIEHS) examined its efficacy in chelating methylmercury exposure among vulnerable populations. Preliminary results suggest a positive trend, though peer-reviewed publication is pending.

Innovations and Formulation Advances

Innovation efforts include modified-release formulations designed to enhance patient compliance and reduce dosing frequency. For instance, a 2022 pilot study evaluated a multi-dose sustained-release capsule, observing comparable efficacy with improved tolerability. If scaled successfully, such innovations could broaden therapeutic applications and increase market adoption.

Regulatory Landscape and Future Trials

While no recent filings for new indications have been granted, regulatory agencies, including the European Medicines Agency (EMA), are reviewing post-marketing data to update treatment guidelines. The FDA has maintained its position, emphasizing the need for continued clinical evaluation, especially in populations with differing heavy metal exposure profiles. Anticipated future trials will likely focus on:

• Broader indications (e.g., mercury, arsenic poisoning)
• Pediatric and special populations
• Combination therapies to mitigate toxicity effectively

---

Market Analysis of Succimer

Current Market Overview

The global chelation therapy market was valued at approximately USD 600 million in 2022, with Succimer accounting for an estimated 35-40% of this segment due to its established efficacy in pediatric lead poisoning.[1] North America remains the dominant market, driven by stringent environmental regulations and high awareness around heavy metal poisoning.

The drug’s market penetration in emerging economies remains limited due to factors such as regulatory hurdles, lack of infrastructure for heavy metal testing, and limited physician familiarity. Nonetheless, increasing environmental pollution and industrial activities in regions such as Asia-Pacific are raising the incidence of heavy metal exposure, indirectly fueling demand for chelation therapies.

Market Drivers

• Rising Incidence of Lead Exposure: Despite regulatory measures, lead poisoning continues to pose a health risk globally, especially in urban and impoverished communities. The CDC estimates that approximately 4 million children in the U.S. have elevated blood lead levels, necessitating chelation therapy.[2]
• Environmental Regulations: Governments worldwide are tightening regulations on industrial emissions, prompting increased screening and treatment efforts.
• Growing Awareness of Heavy Metal Toxicity: Enhanced public health campaigns and clinician awareness contribute to earlier diagnosis and treatment.

Market Challenges

• Limited Indication Expansion: Existing approvals restrict Succimer's use primarily to lead poisoning, limiting growth potential unless new indications are approved.
• Availability and Cost: In some markets, high costs and limited distribution channels restrict access, particularly in low- to middle-income countries.
• Alternative Treatments: Development of novel chelators with improved safety and efficacy profiles poses competition.

Competitive Landscape

Besides Succimer, other chelating agents used globally include calcium disodium edetate (CaNa2EDTA), dimercaprol, and newer agents such as DMPS (dimercapto-propane sulfonate). However, Succimer's favorable oral administration route and safety profile afford it a competitive advantage, especially in outpatient settings.

---

Market Projection and Growth Outlook

Forecast Overview

The chelation therapy market, led chiefly by Succimer, is projected to grow at a compound annual growth rate (CAGR) of approximately 5-7% over the next five years. This growth will be influenced heavily by the persistence of heavy metal exposure issues, therapeutic innovation, and increasing acceptance in emerging markets.

Factors Supporting Growth

• Expansion into New Indications: Pending clinical trials targeting other heavy metals could diversify therapeutic applications. Approval for conditions such as mercury and arsenic poisoning would significantly boost sales.
• Enhanced Formulations and Delivery: Development of sustained-release or targeted delivery systems will likely improve adherence and extend market reach.
• Global Environmental Initiatives: Stricter environmental standards worldwide will increase screening, early detection, and treatment initiation.

Potential Barriers

• Regulatory and Approval Hurdles: Approval delays for new indications or formulations could impact growth trajectories.
• Pricing and Reimbursement Policies: Variations in healthcare coverage, especially in emerging markets, might restrict adoption.
• Emergence of Alternative Therapies: The entry of more potent or safer chelating agents could challenge Succimer’s market share.

Market Opportunities

Given the global burden of heavy metal poisoning, particularly in rapidly industrializing regions, the demand for effective chelation therapies like Succimer is expected to rise substantially. Companies investing in innovative formulations, expanding indications, or entering underserved markets could realize substantial growth opportunities.

---

Conclusion

Succimer remains a pivotal drug in heavy metal chelation, underpinned by a solid safety and efficacy profile. Its clinical landscape, while relatively mature, continues to evolve with ongoing trials exploring expanded indications and novel formulations. The market outlook indicates modest but steady growth driven by increasing environmental heavy metal exposure, regulatory developments, and product innovations.

Stakeholders should monitor clinical pipeline developments, regulatory frameworks, and market dynamics to capitalize on emerging opportunities. Continued research into expanding the therapeutic scope of Succimer, coupled with strategic market penetration, can significantly enhance its global impact.

---

Key Takeaways

• Clinical Trials: While no major new indications have been recently approved, ongoing studies aim to diversify succimer's use, especially in mercury and arsenic poisoning. Innovations focus on improved formulations with enhanced adherence profiles.
• Market Dynamics: Dominated by North America, with growth driven by environmental regulations and increased heavy metal exposure, especially in urban and developing regions.
• Growth Projection: The chelation therapy market is set for a CAGR of approximately 5-7%, supported by expanding indications, formulations, and global environmental initiatives.
• Challenges: Regulatory hurdles, high costs, and competition from novel chelators could impact growth.
• Opportunities: Expansion into new heavy metal indications, improved drug delivery systems, and penetration into emerging markets offer significant upside potential.

---

FAQs

1. What are the primary indications for Succimer currently?
   Succimer is approved for the treatment of lead poisoning in children and adults, particularly to reduce blood lead levels and mitigate toxicity.

2. Are there ongoing clinical trials exploring new uses for Succimer?
   Yes. Studies are investigating its efficacy in arsenic and mercury poisoning, with some preliminary positive findings.

3. What are the advantages of Succimer over other chelating agents?
   Oral administration, favorable safety profile, and proven efficacy in pediatric lead poisoning give Succimer a competitive edge over agents like dimercaprol and EDTA, which often require parenteral administration and have higher side-effect profiles.

4. What factors are influencing Succimer’s market growth?
   Increasing heavy metal exposure, regulatory support, and formulation innovations are key factors. Conversely, availability, costs, and competition restrict growth potential.

5. What is the future outlook for Succimer in global markets?
   The outlook remains positive with expanding indications and formulations, especially in regions experiencing industrial growth and environmental pollution. Strategic efforts are needed to penetrate emerging markets fully.

---

References

1. MarketsandMarkets. “Chelation Therapy Market by Type, Indication, and Region – Global Forecast to 2027.”
2. CDC. “Lead Poisoning Prevention.” Centers for Disease Control and Prevention, 2022.