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NCT00376194 ↗	Mercury Chelation to Treat Autism	Withdrawn	National Institute of Mental Health (NIMH)	Phase 2	2006-09-01	This study will examine whether DMSA, an oral chelating agent that removes mercury and other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.

Clinical Trial Conditions for Succimer

Condition Name

Condition Name for Succimer
Intervention	Trials
Lead Poisoning	2
Autism	2
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive	1
Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive	1

Condition MeSH

Condition MeSH for Succimer
Intervention	Trials
Autistic Disorder	2
Poisoning	2
Lead Poisoning	2
Leukemia, Myelogenous, Chronic, BCR-ABL Positive	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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1
National Institute of Environmental Health Sciences (NIEHS)	1
National Institute of Mental Health (NIMH)	1

Sponsor Type

Sponsor Type for Succimer
Sponsor	Trials
NIH	4
Other	3
Industry	1

Succimer: Clinical Trials, Market Analysis, and Projections

Overview of Succimer

Succimer, also known as dimercaptosuccinic acid (DMSA), is a small molecule drug primarily used for the treatment of lead and mercury poisoning. It was initially developed by Recordati SpA and is currently managed by Recordati Rare Diseases, Inc.[1].

Clinical Trials Update

Several clinical trials are ongoing or have been completed to evaluate the efficacy and safety of succimer in various conditions.

Lead Poisoning

A significant clinical trial involved 780 children with blood lead levels between 20-44 microg/dL. This placebo-controlled, randomized trial showed that succimer-treated children had a significant drop in blood lead levels compared to the placebo group. However, the study also noted an unanticipated excess of trauma in the succimer-treated group, which requires further confirmation[3].

Other Indications

• Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS): A Phase 1 trial is recruiting patients to study the side effects and best dose of succimer or edetate calcium disodium in treating patients with AML or MDS undergoing chemotherapy. The trial aims to lower metal levels in the bone marrow and blood and improve the response to chemotherapy[1].
• Wilson's Disease: Although not directly related to succimer, a study on Wilson's disease mentions the optimization of treatment regimens, which could indirectly influence the use of chelating agents like succimer in similar metal-related disorders[1].

Current Status

• Recruiting Trials: Trials such as the one at the University of Texas MD Anderson Cancer Center are still recruiting participants to study the effects of succimer in patients with AML and MDS[1].
• Suspended Trials: A Phase 3 trial comparing the treatment response to calcium EDTA and succimer in patients with lead poisoning was suspended, highlighting the need for more robust and ongoing research[1].

Market Analysis

Current Market Status

Succimer is primarily used for the chelation of lead and mercury, with its global highest R&D status being approved. It holds an orphan drug designation in the US, which can provide certain market exclusivities and incentives[1].

Market Projections

While there is no direct market projection specifically for succimer, its use is closely tied to the broader market of chelating agents and pharmaceuticals.

• Chelation Therapy Market: The demand for chelation therapy, including drugs like succimer, is influenced by factors such as the prevalence of lead and mercury poisoning, particularly in children. The CDC and other health organizations play a crucial role in managing and treating these conditions, which can impact the market demand for succimer[4].

Impact of Drug Shortages

In recent years, succimer has faced drug shortages, which can significantly impact its market availability and patient access. For instance, a shortage of succimer (CHEMET) by Recordati Rare Diseases was reported and resolved by June 2021. Such shortages can disrupt the market and necessitate the use of alternative chelating agents[4].

Market Trends and Related Industries

Pharmaceutical Industry

The pharmaceutical industry, which includes the market for succimer, is driven by advancements in research and the increasing need for effective treatments. The COVID-19 pandemic had a complex impact on the pharmaceutical market, with some sectors experiencing increased demand while others faced declines. However, the industry has gradually recovered, driven by the resumption of economic activities and advancements in research[2].

Related Chemical Markets

While not directly related to succimer, the markets for related chemicals like succinic acid and succinimide provide insights into broader chemical and pharmaceutical trends.

• Succinic Acid Market: This market is growing at a CAGR of 18.01% and is expected to reach USD 3,613.27 million by 2030. The growth is driven by increasing applications in food, beverages, and pharmaceutical industries[5].
• Succinimide Market: Forecasted to reach around $403.365 million by 2030, this market is driven by demand from pharmaceuticals, liquid crystal displays, and other industrial applications[2].

Safety and Efficacy

Clinical Evidence

Clinical trials have shown that succimer is effective in lowering blood lead levels with few side effects. However, there are some notable adverse effects, such as scalp rashes and an unanticipated increase in trauma, which need further investigation[3].

Regulatory Considerations

The use of succimer is regulated by health authorities, and its administration is based on clinical judgment and a risk-benefit analysis. Factors such as blood lead levels, exposure source, chronicity, symptoms, and nutritional status are considered before initiating chelation therapy[4].

Key Takeaways

• Clinical Trials: Ongoing trials are evaluating succimer's efficacy in treating lead and mercury poisoning, as well as its potential use in other conditions like AML and MDS.
• Market Status: Succimer is approved and holds an orphan drug designation in the US, but its market is subject to fluctuations due to drug shortages and broader pharmaceutical trends.
• Safety and Efficacy: Succimer is effective in reducing blood lead levels but may have side effects that require careful monitoring.
• Market Projections: While specific projections for succimer are limited, the broader pharmaceutical and chelation therapy markets indicate a growing demand driven by research advancements and increasing health needs.

FAQs

What is succimer used for?

Succimer is primarily used for the treatment of lead and mercury poisoning through chelation therapy.

What are the common side effects of succimer?

Common side effects include scalp rashes, and there is an unanticipated excess of trauma that requires further confirmation.

Is succimer approved for use in children?

Yes, succimer is approved for use in children with blood lead levels between 20-44 microg/dL, although its use is subject to careful clinical judgment.

What is the current market status of succimer?

Succimer is approved and holds an orphan drug designation in the US, but it has faced drug shortages in the past.

Are there ongoing clinical trials for succimer?

Yes, there are ongoing clinical trials evaluating the use of succimer in various conditions, including AML and MDS.

How does the COVID-19 pandemic impact the market for succimer?

The pandemic has had a complex impact on the pharmaceutical market, including disruptions in supply chains and fluctuations in demand, but the market has gradually recovered with the resumption of economic activities and research advancements.