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Mecasermin | CAS No: 68562-41-4 | GMP-certified suppliers

A medication that supports treatment of growth failure in children with severe primary IGF‑1 deficiency or GH‑gene‑deletion–related growth issues requiring alternative therapy.

Therapeutic categories

Amino Acids, Peptides, and ProteinsAnterior Pituitary Lobe Hormones and AnaloguesBiological FactorsBlood Glucose Lowering AgentsBlood ProteinsGrowth Substances
Generic name
Mecasermin
Molecule type
biotech
CAS number
68562-41-4
DrugBank ID
DB01277
Approval status
Approved drug, Investigational drug
ATC code
H01AC03

Primary indications

  • For the long-term treatment of growth failure in pediatric patients with Primary IGFD or with GH gene deletion who have developed neutralizing antibodies to GH
  • It is not indicated to treat Secondary IGFD resulting from GH deficiency, malnutrition, hypothyroidism or other causes
  • It is not a substitute for GH therapy

Product Snapshot

  • Mecasermin is supplied primarily as a parenteral recombinant peptide delivered by subcutaneous injection, with some topical and other formats under investigation
  • It is used for managing growth failure associated with primary IGF‑1 deficiency or GH gene deletion with neutralizing antibodies
  • It holds approvals in the US, Canada, and EU, with certain formulations remaining investigational

Clinical Overview

Mecasermin (CAS 68562-41-4) is a recombinant human insulin‑like growth factor‑1 produced in E. coli expressing the human IGF‑1 gene. The molecule contains 70 amino acids with three intramolecular disulfide bridges and matches the endogenous IGF‑1 sequence. It is indicated for long‑term treatment of growth failure in pediatric patients with severe primary IGF‑1 deficiency or in those with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone. It is not suitable for secondary IGF‑1 deficiency and does not replace growth hormone therapy.

The pharmacological activity reflects the physiologic role of IGF‑1 in mediating growth hormone–dependent signaling. Exogenous IGF‑1 binds to the type I IGF‑1 receptor and activates intracellular pathways involved in statural growth. These include mitogenic signaling, chondrocyte proliferation within epiphyseal growth plates, and support of tissue and organ growth. In primary IGF‑1 deficiency, impaired growth hormone pathway function leads to reduced endogenous IGF‑1 despite normal or elevated growth hormone levels; mecasermin compensates for this deficit.

As a peptide biologic, mecasermin displays absorption and elimination characteristics consistent with protein therapeutics, including systemic distribution after subcutaneous administration and metabolism through normal protein degradation pathways. Hypoglycemia is a central safety concern due to the insulin‑like activity of IGF‑1; administration with carbohydrate intake and glucose monitoring are essential. Additional risks include lymphoid tissue hypertrophy, intracranial hypertension, and potential effects on neoplastic growth because of its mitogenic properties.

Mecasermin is marketed in several regions, with Increlex being a commonly referenced brand. Clinical use is restricted to specialized pediatric endocrinology settings.

For API procurement, sourcing should prioritize manufacturers with validated recombinant protein production systems, robust control of host cell protein and DNA impurities, and demonstrated consistency in folding, disulfide‑bridge formation, and potency. Compliance with international biologics manufacturing standards and thorough characterization of critical quality attributes is essential.

Identification & chemistry

Generic name Mecasermin
Molecule type Biotech
CAS 68562-41-4
UNII 7GR9I2683O
DrugBank ID DB01277

Pharmacology

SummaryMecasermin is a recombinant form of human IGF‑1 that replaces deficient endogenous IGF‑1 and activates the type I IGF‑1 receptor to support statural growth. Receptor engagement triggers intracellular signaling that promotes chondrocyte proliferation and tissue growth across multiple organs. Its pharmacologic activity reflects restoration of the IGF‑1 pathway in conditions where GH-driven IGF‑1 production is impaired.
Mechanism of actionMecasermin supplies recombinant-DNA-origin IGF-1, which binds to the Type I IGF-1 receptor. This receptor exerts intra-cellular signaling activity in a number of processes involved in statural growth, including mitogenesis in multiple tissue types, chondrocyte growth and division along cartilage growth plates, and increases in organ growth.
PharmacodynamicsMecasermin is a biosynthetic (recombinant DNA origin) form of human insulin-like growth factor 1 (IGF-1) designed to replace natural IGF-1 in pediatric patients who are deficient, promoting normalized statural growth. Growth hormones (GH) bind to growth hormone receptors (GHR) in the liver and other tissues, which stimulates the synthesis of IGF-1. In target tissues, IGF-1 activates the IGF-1 receptor, resulting in intracellular signals that stimulate growth . Although many actions of the GH are mediated through IGF-1, the precise roles of GH and IGF-1 have not been fully elucidated. Patients with severe primary IGF-1 deficiency (Primary IGFD) fail to produce adequate levels of IGF-1, due to disruption of the GH pathway used to promote IGF-1 release (possible GH pathway disruptions include mutations in the GHR, post-GHR signaling pathway, and IGF-1 gene defects).
Targets
TargetOrganismActions
Insulin-like growth factor 1 receptorHumansagonist
Insulin-like growth factor-binding protein 3Humans
Insulin receptorHumans

ADME / PK

AbsorptionWhile the bioavailability of rhIGF-1 after subcutaneous administration in healthy subjects has been reported to be close to 100%, the absolute bioavailability of mecasermin given subcutaneously to subjects with primary insulin-like growth factor-1 deficiency (Primary IGFD) has not been determined.
Half-lifeMean half life of 5.8 hours
Protein bindingIn blood, IGF-1 is bound to six IGF binding proteins, with > 80% bound as a complex with IGFBP-3 and an acid-labile subunit .
MetabolismInformation on the metabolism of Mecasermin is not readily available, however it is likely to be metabolized by the liver and kidney like other injectable peptide drugs.
Route of eliminationInformation on the elimination of Mecasermin is not readily available, however it is likely to be metabolized by the liver and kidney like other injectable peptide drugs.
Volume of distribution* 0.257 ± 0.073 L/kg [subjects with severe Primary IGFD] at a dose of 0.045mg/kg
ClearanceClearance of Mecasermin is inversely proportional to IGF binding protein 3 (IGFBP-3) * Clearance is estimated to be 0.04L/hr/kg at 0.5 micrograms/mL of IGFBP-3 * Clearance is estimated to be 0.01L/hr/kg at 3 micrograms/mL of IGFBP-3 (the median level of IGFBP-3 for patients with normal IGF-1 levels)

Formulation & handling

  • Mecasermin is a recombinant peptide growth factor requiring parenteral formulation; subcutaneous solutions need protection from aggregation and should avoid vigorous agitation.
  • As a biotech protein, it is sensitive to temperature excursions and requires cold‑chain handling and stabilizing excipients to maintain structural integrity.
  • Formulations are typically administered with food due to hypoglycemia risk, which should be considered when designing clinical‑use instructions and labeling.

Regulatory status

LifecycleThe API’s key U.S. patents expired in 2010 and 2017, indicating that it is now in a mature, post‑exclusivity phase. With products marketed in the US, Canada, and the EU, the ingredient is established across major regulated markets.
MarketsUS, Canada, EU
Supply Chain
Supply chain summaryMecasermin supply is centered on a small number of originator and licensed manufacturers, with products packaged and distributed by several established pharmaceutical entities. Commercial availability spans the US, Canada, and parts of the EU, reflecting a controlled but multinational branded presence. Core U.S. patents expired in 2010 and 2017, indicating that market conditions allow for existing or potential generic competition depending on regulatory approvals.

Safety

ToxicityOverdosage of Mecasermin leads to hypoglycemia. One case of acute overdose was treated with IV glucose. Long-term overdosage may result in signs and symptoms of acromegaly. The effects of Mecasermin in human pregnancy has not been studied, however effects on fetal development in animal studies were only seen at doses higher than the maximum recommended human dose based on body surface area. Studies on excretion of the drug in human milk, use in patients under 2 years, use in patients over 65 years, or use in patients with renal or hepatic impairment have not been performed.
High Level Warnings:
  • Acute overexposure may precipitate significant hypoglycemia
  • Prolonged excessive exposure has been associated with acromegaly‑like manifestations
  • Reproductive and developmental risk characterization is incomplete

Mecasermin is a type of Somatropin Agonists


Somatropin agonists are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are designed to mimic the action of the natural human growth hormone, somatropin. These agonists are developed to interact with specific receptors in the body, promoting growth and development.

Somatropin agonists have gained significant attention in the pharmaceutical industry due to their potential applications in various medical conditions. They are primarily used in the treatment of growth disorders, such as growth hormone deficiency in children and adults. By binding to the somatropin receptor, these agonists stimulate the production of insulin-like growth factor-1 (IGF-1), which is responsible for promoting tissue growth and development.

One of the advantages of somatropin agonists is their enhanced stability and bioavailability compared to naturally occurring somatropin. This allows for better control of dosage and consistent therapeutic effects. Furthermore, these agonists can be administered through various routes, including subcutaneous injection, making them convenient for patients.

The development of somatropin agonists involves rigorous research and optimization to ensure their safety and efficacy. Pharmaceutical companies employ advanced techniques, such as recombinant DNA technology, to produce these synthetic analogs. Quality control measures are implemented throughout the manufacturing process to ensure batch-to-batch consistency and adherence to regulatory standards.

In conclusion, somatropin agonists are a valuable subcategory of pharmaceutical APIs used in the treatment of growth disorders. Their ability to mimic the action of somatropin and promote tissue growth makes them a promising therapeutic option for patients in need. Ongoing research and development in this field aim to further enhance the efficacy and safety of somatropin agonists, providing improved treatment options for individuals with growth-related conditions.


Mecasermin (Somatropin Agonists), 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.



Mecasermin API manufacturers & distributors

Compare qualified Mecasermin API suppliers worldwide. We currently have 1 companies offering Mecasermin API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Distributor
United States China CoA, FDA, MSDS7 products

When sending a request, specify which Mecasermin 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.).

Use the list above to find high-quality Mecasermin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.

We show synonyms and CAS numbers for Mecasermin API to help you connect with the right supplier. However, a synonym or CAS number does not always mean it is exactly the same specification. Always confirm the final specs directly with the supplier before placing an order.

Frequently asked questions about Mecasermin API


Sourcing

What matters most when sourcing GMP-grade Mecasermin?
Key considerations include confirming GMP compliance and alignment with regulatory requirements in the US, Canada, and relevant EU markets. Because supply comes from a small number of originator and licensed manufacturers, verifying the manufacturer’s authorization and supply reliability is essential. It is also important to account for the controlled multinational distribution framework and the potential for generic competition due to expired core U.S. patents.
Which documents are typically required when sourcing Mecasermin API?
Request the core API documentation set: FDA (1 company), CoA (1 company), MSDS (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Mecasermin API?
Known or reported manufacturers for Mecasermin: Attix Pharmaceuticals. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Mecasermin API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Mecasermin manufacturers?
Audit reports may be requested for Mecasermin: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Mecasermin API on Pharmaoffer?
Reported supplier count for Mecasermin: 1 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Mecasermin API?
Production countries reported for Mecasermin: China (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Mecasermin usually hold?
Common certifications for Mecasermin suppliers: FDA (1 company), CoA (1 company), MSDS (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Mecasermin (CAS 68562-41-4) used for?
Mecasermin is used for long‑term treatment of growth failure in children with severe primary IGF‑1 deficiency or with growth hormone gene deletion that has led to neutralizing antibodies against growth hormone. It provides recombinant human IGF‑1 to activate IGF‑1 receptor–mediated signaling required for normal statural growth. It is not used for secondary IGF‑1 deficiency and does not substitute for growth hormone therapy.
Which therapeutic class does Mecasermin fall into?
Mecasermin belongs to the following therapeutic categories: Amino Acids, Peptides, and Proteins, Anterior Pituitary Lobe Hormones and Analogues, Biological Factors, Blood Glucose Lowering Agents, Blood Proteins. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Mecasermin mainly prescribed for?
The primary indications for Mecasermin: For the long-term treatment of growth failure in pediatric patients with Primary IGFD or with GH gene deletion who have developed neutralizing antibodies to GH, It is not indicated to treat Secondary IGFD resulting from GH deficiency, malnutrition, hypothyroidism or other causes, It is not a substitute for GH therapy. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Mecasermin work?
Mecasermin supplies recombinant-DNA-origin IGF-1, which binds to the Type I IGF-1 receptor. This receptor exerts intra-cellular signaling activity in a number of processes involved in statural growth, including mitogenesis in multiple tissue types, chondrocyte growth and division along cartilage growth plates, and increases in organ growth.
What should someone know about the safety or toxicity profile of Mecasermin?
Mecasermin can cause significant hypoglycemia, particularly with acute overexposure, due to its insulin‑like activity. Prolonged excessive exposure may lead to acromegaly‑like manifestations, and its mitogenic properties raise concerns about effects on lymphoid tissue and other growing tissues. Intracranial hypertension has been observed, and reproductive and developmental risks are not fully characterized. Careful dosing and glucose monitoring are essential to mitigate these safety concerns.
What are important formulation and handling considerations for Mecasermin as an API?
Important considerations include maintaining protein stability, as Mecasermin is a recombinant peptide that is sensitive to temperature excursions, agitation, and aggregation. Parenteral formulations require stabilizing excipients and cold‑chain handling to preserve structural integrity. Subcutaneous solutions should be protected from vigorous mixing, and use‑related instructions must account for administration with food due to hypoglycemia risk.
Is Mecasermin a biotech?
Mecasermin is classified as a biotech. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Mecasermin?
Mecasermin is not formulated for oral use; it is a recombinant peptide growth factor that requires parenteral administration. Stability concerns relate to its sensitivity to temperature excursions and the need for cold‑chain handling. Subcutaneous solutions must be protected from aggregation and handled gently to avoid structural degradation.

Regulatory

Where is Mecasermin approved or in use globally?
Mecasermin is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Mecasermin right now?
Mecasermin is authorized for use in the United States, Canada, and the European Union. Its regulatory status in these regions supports controlled clinical use under established prescribing guidelines. Patent protections for Mecasermin vary by jurisdiction and are defined by the specific filings and expiration timelines recorded in national and international patent databases. For an accurate assessment, the relevant patent registers should be consulted.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Mecasermin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Mecasermin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Mecasermin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Mecasermin: . Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Mecasermin?
Market report availability for Mecasermin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.