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Cysteamine | CAS No: 60-23-1 | GMP-certified suppliers
A medication that treats nephropathic cystinosis and cystinuria systemically and reduces corneal cystine crystal accumulation in ocular cystinosis patients aged six years and older.
Therapeutic categories
Primary indications
- The bitartrate salt of cysteamine is used for the oral treatment of nephropathic cystinosis and cystinuria in adults and children ≥6 years old
- The hydrochloride salt, used in eye drop preparations, is indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis
Product Snapshot
- Cysteamine is available as oral capsules, granules, solutions, and ophthalmic drops, suitable for both systemic and topical application
- It is primarily used for treating nephropathic cystinosis, cystinuria, and corneal cystine crystal accumulation
- The compound holds approval or investigational status in key regulatory markets including the US, Canada, and the EU
Clinical Overview
Clinically, cysteamine is available in oral bitartrate salt form for the treatment of nephropathic cystinosis and cystinuria in patients aged six years and older. Additionally, the hydrochloride salt is formulated as an ophthalmic solution to address corneal cystine crystal accumulation in patients with ocular cystinosis. Oral cysteamine acts systemically to reduce lysosomal cystine levels primarily in renal and other affected tissues, while topical ophthalmic formulations directly target corneal deposits.
Pharmacodynamically, cysteamine facilitates the conversion of cystine into cysteine and cysteine-cysteamine mixed disulfides, compounds that can exit lysosomes via alternative transport mechanisms independent of defective cystinosin. This thiol-disulfide exchange reduces intracellular cystine accumulation, thereby preventing or delaying tissue damage. Untreated cystinosis can lead to progressive renal failure during childhood and involvement of other organs including the central nervous system, thyroid, pancreas, muscle, and gonads.
Key ADME parameters of cysteamine include rapid absorption following oral administration and metabolism primarily by hepatic pathways, with elimination of metabolites via renal excretion. The pharmacokinetic profile supports frequent dosing to maintain effective tissue cystine depletion. Ophthalmic cysteamine formulations have evolved to allow reduced dosing frequency, reflecting improved patient adherence.
Safety considerations for cysteamine include potential gastrointestinal disturbances with oral use, as well as rare instances of dermatologic and neurologic adverse effects. Ocular formulations are generally well tolerated but require consistent application to maintain efficacy.
On August 25, 2020, the FDA approved a novel ophthalmic cysteamine preparation requiring only four daily instillations, marketed as CYSTADROPS® by Recordati Rare Diseases Inc. This innovation represents a significant improvement over previous therapies necessitating hourly application.
When sourcing cysteamine as an active pharmaceutical ingredient, quality considerations include verification of chemical purity, especially the thiol content and absence of oxidation products, as well as compliance with pharmacopeial standards. Stability under handling and storage conditions is critical given the compound’s susceptibility to oxidation. Manufacturers must adhere to Good Manufacturing Practice (GMP) guidelines to ensure reproducible quality suitable for pharmaceutical formulations.
Identification & chemistry
| Generic name | Cysteamine |
|---|---|
| Molecule type | Small molecule |
| CAS | 60-23-1 |
| UNII | 5UX2SD1KE2 |
| DrugBank ID | DB00847 |
Pharmacology
| Summary | Cysteamine acts by converting intracellular cystine into cysteine and cysteine-cysteamine mixed disulfides, facilitating cystine efflux from lysosomes and reducing pathological cystine accumulation. This mechanism targets cystine crystals responsible for tissue damage in cystinosis, particularly in renal and corneal tissues. The drug’s pharmacodynamics focus on preventing organ injury by decreasing intracellular cystine concentrations. |
|---|---|
| Mechanism of action | Individuals born without the ability to metabolize cystine suffer from cystinosis, a rare genetic disorder characterized by the widespread accumulation of cystine crystals throughout the body and eye tissues. The cystine crystals may cause considerable damage, particularly in the renal tissues and corneal tissues. In some cases, renal failure can occur during childhood if the condition is left untreated. Other organs that may be affected by cystinosis include the CNS, thyroid, pancreas, muscle tissues, and gonads. Cysteamine converts cystine to cysteine and cysteine-cysteamine mixed disulfides, reducing the buildup of corneal cystine crystals. This drug participates in a thiol-disulfide interchange reaction with lysosomes, leading to cysteine exit from the lysosome in patients diagnosed with cystinosis. |
| Pharmacodynamics | Cystine accumulation is the cause of organ damage in cystinosis. Cysteamine prevents the accumulation of cystine crystals in the body and is specifically prescribed to prevent kidney and eye damage. Cysteamine converts cystine into a form that may easily exit cells, preventing harmful accumulation. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Cystine | Humans | cleavage |
| Neuropeptide Y receptor type 2 | Humans | other/unknown |
ADME / PK
| Absorption | Orally administered cysteamine is absorbed in the gastrointestinal tract and reaches its maximum plasma concentration in about 1.4 hours, with some variation according to the type of formulation (delayed versus immediate-release). One pharmacokinetic study of adults with Cystic Fibrosis revealed a Cmax of 2.86 mg/L.The maximum plasma concentration after administration of cysteamine eye drops is unknown, however, it is likely to be considerably lower than oral administration. According to prescribing information, the AUC 0-12 h for the delayed-release oral tablets is 99.26 ± 44.2 μmol*h/L with a Cmax of 27.70 ± 14.99 μmol/L. The AUC 0-12 for the immediate-release tablets is 192.00 ± 75.62 μmol*h/L with a Cmax of 37.72 ± 12.10 μmol/L. |
|---|---|
| Half-life | The half-life of cysteamine is about 3.7 hours. |
| Protein binding | Cysteamine is 52% plasma protein bound, and is mostly bound to albumin. |
| Metabolism | There is limited information in the literature regarding the metabolism of cysteamine. This drug undergoes significant first-pass metabolism. |
| Volume of distribution | Cysteamine has a volume of distribution of about 129 L, according to one pharmacokinetic study. Prescribing information indicates a volume of distribution of 382 L for the delayed-release formulation and 198 L for the immediate-release preparation. It is known to cross the blood-brain barrier. |
| Clearance | The plasma clearance of cysteamine is about 1.2 - 1.4 L/min. One reference mentions a clearance of 89.9 L/h in patients with Cystic Fibrosis. |
Formulation & handling
- Cysteamine is available in both oral and ophthalmic formulations indicating versatility in administration routes.
- As a small molecule alkylthiol, it requires careful handling due to its thiol functional group, which may be prone to oxidation.
- Oral delayed-release formulations should be administered on an empty stomach or timed around high-fat meals to ensure consistent bioavailability.
Regulatory status
| Lifecycle | The API is marketed in the US, Canada, and EU, with key patents in the US expiring between 2027 and 2034. This indicates a phased lifecycle with initial market exclusivity expected to continue until at least 2027, followed by extended protection for certain aspects until 2034. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Cysteamine is primarily manufactured and packaged by a single originator company with branded products available in the US, Canada, and EU markets. Multiple patents are active in the United States, with expiration dates ranging from 2027 to 2034, indicating that generic competition may begin emerging after mid-2027, with extended exclusivity potentially maintained in certain formulations until 2034. |
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Safety
| Toxicity | Two cases of human overdoses with cysteamine are recorded in the literature, according to prescribing information. In one case, vomiting was immediate after the administration of cysteamine, and the patient did not experience other symptoms. A 200 to 250 mg/kg dose was accidentally ingested by a healthy 13-month-old child. Vomiting and dehydration followed. A full recovery was made after hospitalization and the replenishment of fluids. There is no known antidote for an overdose with cysteamine. In the case of an overdose, provide supportive treatment, especially to the cardiovascular and respiratory systems. Hemodialysis may be useful in some cases due to the fact that cysteamine has poor plasma protein binding. |
|---|
- Cysteamine has a low plasma protein binding and may be partially removed by hemodialysis in overdose situations
- Overdose cases have shown acute vomiting and dehydration
- There is no specific antidote available
Cysteamine is a type of Means in metabolic disorders
The pharmaceutical API subcategory of means in metabolic disorders refers to a group of active pharmaceutical ingredients (APIs) that are utilized in the treatment of various metabolic disorders. Metabolic disorders are medical conditions that involve disruptions in the normal metabolic processes of the body, such as those related to glucose metabolism, lipid metabolism, or hormone regulation.
The means in metabolic disorders APIs encompass a diverse range of compounds that target specific pathways or enzymes involved in metabolic regulation. These APIs play a crucial role in managing conditions like diabetes, obesity, hyperlipidemia, and hormonal imbalances. They are often incorporated into medications designed to improve metabolic function and restore the balance of key biomolecules in the body.
Common APIs in this subcategory include biguanides, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, and sodium-glucose co-transporter 2 (SGLT2) inhibitors. These APIs exert their effects through various mechanisms such as enhancing insulin sensitivity, increasing insulin secretion, reducing glucose production, and promoting weight loss.
The development of means in metabolic disorders APIs involves extensive research and rigorous testing to ensure their efficacy, safety, and compatibility with existing treatment regimens. Pharmaceutical companies collaborate with researchers and regulatory authorities to conduct clinical trials and obtain necessary approvals before these APIs can be integrated into commercial medications.
In summary, means in metabolic disorders APIs are a vital component of pharmaceutical interventions aimed at managing metabolic disorders. By targeting specific metabolic pathways, these APIs contribute to improving patient outcomes and enhancing their overall quality of life.
Cysteamine (Means in metabolic disorders), classified under Metabolic Bone Disease Agents
Metabolic Bone Disease Agents are a category of pharmaceutical active pharmaceutical ingredients (APIs) that are specifically designed to treat and manage conditions related to the bones and their metabolism. These agents play a crucial role in the treatment of various metabolic bone diseases, including osteoporosis, Paget's disease, and rickets.
The primary function of Metabolic Bone Disease Agents is to regulate bone remodeling and maintain bone health. They achieve this by targeting specific pathways involved in bone metabolism, such as osteoclast and osteoblast activity, calcium regulation, and vitamin D metabolism.
These APIs are commonly used in the development of medications, including oral tablets, injectables, and topical formulations, for the effective treatment of metabolic bone diseases. They are carefully formulated to optimize their pharmacokinetic and pharmacodynamic properties, ensuring maximum efficacy and minimal side effects.
Metabolic Bone Disease Agents encompass a range of substances, including bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, and vitamin D analogs. These APIs act through different mechanisms to address specific aspects of bone health, such as inhibiting bone resorption, promoting bone formation, or regulating calcium levels.
In conclusion, Metabolic Bone Disease Agents are a vital category of pharmaceutical APIs used in the development of medications for the treatment and management of various metabolic bone diseases. These agents target specific pathways involved in bone metabolism to regulate bone remodeling, enhance bone health, and alleviate the symptoms associated with these conditions.
Cysteamine API manufacturers & distributors
Compare qualified Cysteamine API suppliers worldwide. We currently have 4 companies offering Cysteamine API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Cambrex | Producer | Italy | Unknown | CoA, JDMF, USDMF | 104 products |
| Dr. Sahu's Laboratories | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, MSDS | 70 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
When sending a request, specify which Cysteamine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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