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Tetracosactide | CAS No: 16960-16-0 | GMP-certified suppliers
A medication that serves as a diagnostic agent for screening adrenocortical insufficiency by stimulating adrenal corticosteroid synthesis to assess adrenal function accurately.
Therapeutic categories
Primary indications
- For use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency
Product Snapshot
- Tetracosactide is available as a parenteral injectable peptide formulation including lyophilized powders and solutions for intravenous and intramuscular administration
- Its primary use is as a diagnostic agent for screening adrenocortical insufficiency
- The product is approved for use in key regulatory markets including the US and Canada
Clinical Overview
Pharmacodynamically, tetracosactide mimics the actions of natural ACTH by binding to melanocortin 2 receptors located on the adrenal cortex. This binding activates the initial enzymatic processes that convert cholesterol into adrenal steroids such as cortisol, cortisone, weak androgens, and small quantities of aldosterone. The peptide demonstrates equivalent maximum adrenal stimulation at a dose of 0.25 mg compared to 25 units of native ACTH. Notably, tetracosactide exhibits reduced immunogenicity because it lacks the amino acid sequence responsible for antigenic activity in full-length ACTH. It also exerts minor additional effects, including melanotropic activity and increased growth hormone secretion; however, these are considered clinically insignificant.
Pharmacokinetic data indicate that tetracosactide absorption in humans occurs over an extended period relative to corticotropin, allowing for less frequent dosing in therapeutic contexts. In individuals with normal adrenal function, it significantly elevates plasma corticosteroid levels, whereas in cases of primary or secondary adrenal insufficiency, a cortisol response is diminished or absent.
Safety considerations relate primarily to its peptide nature and potential for hypersensitivity reactions. Due to its diagnostic use, tetracosactide administration is typically controlled and limited to clinical settings. It is approved for use in multiple jurisdictions and is sold under various brand names, including formulations referenced as Cosyntropin.
For API procurement, ensuring synthetic origin with high purity and peptide chain fidelity is crucial to maintain consistent biological activity and minimize immunogenicity. Compliance with pharmacopoeial standards and rigorous quality control measures are essential, given the peptide’s sensitivity to degradation and the clinical importance of its diagnostic accuracy.
Identification & chemistry
| Generic name | Tetracosactide |
|---|---|
| Molecule type | Small molecule |
| CAS | 16960-16-0 |
| UNII | 72YY86EA29 |
| DrugBank ID | DB01284 |
Pharmacology
| Summary | Cosyntropin acts as an adrenocorticotropic hormone receptor agonist, stimulating adrenal cortical cells to initiate steroidogenesis, primarily increasing cortisol and other adrenal steroids synthesis from cholesterol. Its pharmacodynamic profile replicates natural ACTH's corticosteroidogenic activity while exhibiting reduced immunogenicity due to a truncated amino acid sequence. Cosyntropin is primarily utilized for diagnostic evaluation of adrenal insufficiency by assessing adrenocortical responsiveness. |
|---|---|
| Mechanism of action | Cosyntropin combines with a specific receptor in the adrenal cell plasma membrane and, in patients with normal adrenocortical function, stimulates the initial reaction involved in the synthesis of adrenal steroids (including cortisol, cortisone, weak androgenic substances, and a limited quantity of aldosterone) from cholesterol by increasing the quantity of the substrate within the mitochondria. Cosyntropin does not significantly increase plasma cortisol concentration in patients with primary or secondary adrenocortical insufficiency. |
| Pharmacodynamics | Cosyntropin exhibits the full corticosteroidogenic activity of natural ACTH. Various studies have shown that the biologic activity of ACTH resides in the N- terminal portion of the molecule and that the 1-20 amino acid residue is the minimal sequence retaining full activity. Partial or complete loss of activity is noted with progressive shortening of the chain beyond 20 amino acid residue. For example, the decrement from 20 to 19 results in a 70% loss of potency. The pharmacologic profile of Cosyntropin is similar to that of purified natural ACTH. It has been established that 0.25 mg of Cosyntropin will stimulate the adrenal cortex maximally and to the same extent as 25 units of natural ACTH. Cosyntropin has less immunogenic activity than ACTH because the amino acid sequence having most of the antigenic activity of ACTH, i.e., amino acids 25-39, is not present in cosyntropin. The extra-adrenal effects which natural ACTH and Cosyntropin have in common include increased melanotropic activity, increased growth hormone secretion and an adipokinetic effect. These are considered to be without physiological or clinical significance. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Adrenocorticotropic hormone receptor | Humans | agonist |
ADME / PK
| Absorption | Rapidly absorbed following intramuscular administration. |
|---|---|
| Half-life | About 15 minutes following intravenous administration. |
Formulation & handling
- Tetracosactide is a polypeptide API formulated primarily for parenteral use via intramuscular or intravenous administration.
- The API exhibits low water solubility, necessitating lyophilized powder forms for reconstitution prior to injection to ensure stability.
- Given its peptide nature, careful handling and storage are required to maintain structural integrity and prevent degradation.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is marketed in the US and Canada with patent protection recently expired, leading to increased availability of generic versions and a shift toward market maturity. Ongoing regulatory approvals support continued product presence across these markets. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Tetracosactide includes multiple originator and generic packagers such as Amphastar Pharmaceuticals, Generamedix Inc., and Sandoz, primarily serving the US and Canadian markets. Branded products like Cortrosyn have a strong presence in these regions, with no explicit data indicating availability in the EU or other markets. Patent expiry status suggests the presence of existing generic competition, as multiple generic packagers offer the product. |
|---|
Cosyntropin is a type of Corticotropic hormones
Corticotropic hormones, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in regulating various physiological processes in the human body. These hormones are primarily secreted by the anterior pituitary gland and are responsible for controlling the production and release of glucocorticoids, which are essential for maintaining homeostasis and managing stress.
Corticotropic hormones are mainly comprised of adrenocorticotropic hormone (ACTH), which stimulates the adrenal glands to produce cortisol, a vital stress hormone. This hormone influences multiple bodily functions, including metabolism, immune response, and blood pressure regulation. Additionally, corticotropic hormones also play a significant role in controlling inflammation and allergic reactions.
Pharmaceutical companies often utilize corticotropic hormones as APIs to develop medications that can effectively regulate adrenal function. These medications are commonly prescribed for individuals suffering from conditions such as adrenal insufficiency, autoimmune disorders, and certain types of cancer.
By harnessing the therapeutic potential of corticotropic hormones, pharmaceutical manufacturers can develop drugs that provide relief to patients experiencing adrenal dysfunction. These APIs can be formulated into various dosage forms, including tablets, injections, and topical creams, to cater to different patient needs.
Overall, corticotropic hormones are vital pharmaceutical APIs that offer immense potential in managing adrenal disorders and related conditions. Through continued research and development, these APIs have the potential to revolutionize the treatment landscape and improve the quality of life for countless individuals worldwide.
Cosyntropin (Corticotropic hormones), classified under Hormonal Agents
Hormonal agents are a prominent category of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the medical field. These substances play a crucial role in regulating and modulating hormonal functions within the body. Hormonal agents are designed to mimic or manipulate the effects of naturally occurring hormones, allowing healthcare professionals to treat various endocrine disorders and hormonal imbalances.
Hormonal agents are commonly employed in the treatment of conditions such as hypothyroidism, hyperthyroidism, diabetes, and hormonal cancers. These APIs work by interacting with specific hormone receptors, either by stimulating or inhibiting their activity, to restore the balance of hormones in the body. They can be administered orally, intravenously, or through other routes depending on the specific medication and patient needs.
Pharmaceutical companies employ rigorous manufacturing processes and quality control measures to ensure the purity, potency, and safety of hormonal agent APIs. These APIs are synthesized using chemical or biotechnological methods, often starting from natural hormone sources or through recombinant DNA technology. Stringent regulatory guidelines are in place to guarantee the efficacy and safety of hormonal agent APIs, ensuring that patients receive high-quality medications.
As the demand for hormone-related therapies continues to grow, ongoing research and development efforts focus on enhancing the effectiveness and reducing the side effects of hormonal agent APIs. This includes the exploration of novel delivery systems, advanced formulations, and targeted drug delivery methods. By continuously advancing our understanding and capabilities in hormonal agents, the medical community can improve patient outcomes and quality of life for individuals with hormonal disorders.
Cosyntropin API manufacturers & distributors
Compare qualified Cosyntropin API suppliers worldwide. We currently have 2 companies offering Cosyntropin 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 |
|---|---|---|---|---|---|
| BCN Peptides | Producer | Spain | Spain | CoA, USDMF | 13 products |
| Hemmo Pharma | Producer | India | India | CoA, GMP, WC | 13 products |
When sending a request, specify which Cosyntropin 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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