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Succimer | CAS No: 304-55-2 | GMP-certified suppliers
A medication that treats pediatric lead poisoning and heavy metal toxicities by chelating lead, mercury, and arsenic to reduce systemic metal burden and facilitate excretion.
Therapeutic categories
Acids, AcyclicAntidotesChelating AgentsCompounds used in a research, industrial, or household settingDicarboxylic AcidsLead Chelating Activity
Generic name
Succimer
Molecule type
small molecule
CAS number
304-55-2
DrugBank ID
DB00566
Approval status
Approved drug
Primary indications
- For the treatment of lead poisoning in pediatric patients with blood lead levels above 45 µ
- G/dL
- May also be used to treat mercury or arsenic poisoning
Product Snapshot
- Succimer is available as an oral capsule and intravenous lyophilized powder for solution
- It is primarily used for the treatment of lead poisoning and may also address mercury or arsenic poisoning
- The product is FDA approved and marketed in the United States
Clinical Overview
Succimer (CAS Number 304-55-2) is a mercaptodicarboxylic acid classified as a thia fatty acid derivative. It is primarily indicated for the treatment of lead poisoning in pediatric patients presenting with blood lead levels exceeding 45 μg/dL. Additionally, succimer may be employed to manage poisoning from mercury or arsenic exposure.
Pharmacologically, succimer functions as an orally active chelating agent that forms stable, water-soluble complexes with heavy metal ions. Its mechanism of action involves the binding of heavy metals such as lead, mercury, cadmium, and arsenic through its sulfhydryl groups, facilitating their mobilization from tissues and increasing renal excretion via urine. Succimer’s selectivity for lead ions makes it effective in reducing systemic lead burden following toxic exposures.
Key pharmacokinetic parameters include oral bioavailability enabling systemic chelation, though detailed absorption, distribution, metabolism, and excretion (ADME) profiles vary and are subject to clinical context. Succimer is not indicated for prophylactic use in environments with persistent lead exposure, underscoring the necessity for concurrent identification and removal of the lead source to prevent re-exposure and maximize therapeutic benefit.
Safety and toxicity considerations require monitoring for potential adverse effects related to chelation therapy, including transient elevations in hepatic enzymes and gastrointestinal disturbances. The drug’s safety profile supports its use in pediatric patients under appropriate clinical supervision. Succimer’s use is well established and approved in various regulatory jurisdictions for heavy metal detoxification therapies.
In the context of API sourcing and quality assurance, procurement of succimer requires adherence to stringent purity standards to ensure chelating efficacy and minimize impurities that could affect safety or stability. Suppliers should provide certification of analysis confirming compliance with pharmacopeial specifications and demonstrate consistent batch-to-batch quality suitable for pharmaceutical development and manufacture.
Pharmacologically, succimer functions as an orally active chelating agent that forms stable, water-soluble complexes with heavy metal ions. Its mechanism of action involves the binding of heavy metals such as lead, mercury, cadmium, and arsenic through its sulfhydryl groups, facilitating their mobilization from tissues and increasing renal excretion via urine. Succimer’s selectivity for lead ions makes it effective in reducing systemic lead burden following toxic exposures.
Key pharmacokinetic parameters include oral bioavailability enabling systemic chelation, though detailed absorption, distribution, metabolism, and excretion (ADME) profiles vary and are subject to clinical context. Succimer is not indicated for prophylactic use in environments with persistent lead exposure, underscoring the necessity for concurrent identification and removal of the lead source to prevent re-exposure and maximize therapeutic benefit.
Safety and toxicity considerations require monitoring for potential adverse effects related to chelation therapy, including transient elevations in hepatic enzymes and gastrointestinal disturbances. The drug’s safety profile supports its use in pediatric patients under appropriate clinical supervision. Succimer’s use is well established and approved in various regulatory jurisdictions for heavy metal detoxification therapies.
In the context of API sourcing and quality assurance, procurement of succimer requires adherence to stringent purity standards to ensure chelating efficacy and minimize impurities that could affect safety or stability. Suppliers should provide certification of analysis confirming compliance with pharmacopeial specifications and demonstrate consistent batch-to-batch quality suitable for pharmaceutical development and manufacture.
Identification & chemistry
| Generic name | Succimer |
|---|---|
| Molecule type | Small molecule |
| CAS | 304-55-2 |
| UNII | DX1U2629QE |
| DrugBank ID | DB00566 |
Pharmacology
| Summary | Succimer is an orally active chelating agent that binds with high affinity to heavy metal ions including lead, mercury, cadmium, and arsenic. It forms water-soluble complexes that facilitate renal excretion of these toxic metals from the bloodstream. Succimer is primarily utilized to reduce elevated blood lead levels by enhancing urinary elimination of lead and other heavy metals. |
|---|---|
| Mechanism of action | Succimer is a heavy metal chelator. It binds with high specificity to ions of lead in the blood to form a water-soluble complex that is subsequently excreted by the kidneys. Succimer can also chelate mercury, cadmium, and arsenic in this manner. |
| Pharmacodynamics | Succimer is an orally active, heavy metal chelating agent. It forms water soluble chelates and, consequently, increases the urinary excretion of lead. Succimer is not to be used for prophylaxis of lead poisoning in a lead-containing environment. In addition, the use of succimer should always be accompanied by identification and removal of the source of the lead exposure. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Lead | Humans | chelator |
| Mercury | Humans | chelator |
| Cadmium | Humans | chelator |
ADME / PK
| Absorption | Rapid but variable. |
|---|---|
| Half-life | 48 hours |
| Metabolism | Chemical analysis of succimer and its metabolites (primarily mixed disulfides of L-cysteine) in the urine showed that succimer was rapidly and extensively metabolized however the specific site of biotransformation is not known. |
| Route of elimination | Unabsorbed drug is excreted primarily in feces and absorbed drug is excreted primarily in the urine as metabolites. |
Formulation & handling
- Succimer is a small molecule thia fatty acid derivative available in both oral capsules and intravenous lyophilized powder formulations.
- The compound exhibits moderate water solubility and low lipophilicity (LogP 0.26), suggesting balanced aqueous and membrane interactions.
- Oral administration shows no food sensitivity, permitting dosing with or without meals and offering flexibility in patient administration.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is approaching patent expiry in the US, indicating an increase in generic competition and a transition toward market maturity. Consequently, product availability is expected to expand with more cost-effective alternatives. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Succimer is manufactured and packaged by multiple originator companies, including Lundbeck Inc. and GE Healthcare Inc., indicating collaboration among established pharmaceutical firms. Its branded products are primarily present in the US market, with no mention of EU or other global regions. The presence of multiple brands and manufacturers suggests potential for generic competition, although specific patent expiry information is not provided. |
|---|
Safety
| Toxicity | Oral LD<sub>50</sub> in mice is over 5011 mg/kg. Doses of 2300 mg/kg in the rat and 2400 mg/kg in the mouse produced ataxia, convulsions, labored respiration and frequently death. No case of overdosage has been reported in humans. Limited data indicate that succimer is dialyzable. |
|---|
High Level Warnings:
- Oral LD50 in mice exceeds 5011 mg/kg, indicating low acute toxicity
- High doses (≥2300 mg/kg) in rodents caused neurological and respiratory adverse effects
- Limited evidence suggests succimer can be removed via dialysis
