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Ibutamoren Injection, namely ibutamoren injection, is a drug that has not been widely approved for clinical use yet. However, due to its unique pharmacological mechanism of action, it has attracted attention in scientific research and specific medical fields. Ibutamoren (also known as MK-677, L-163191, etc.) is an oral active growth hormone secretinogen (GHS), and its injectable dosage form may be used in specific research or medical situations. This drug mainly regulates the secretion of growth hormone (GH) by the pituitary gland by activating the growth hormone-stimulating hormone receptor (GHSR), and indirectly affects the level of insulin-like growth factor-1 (IGF-1), thereby exerting multi-dimensional effects on metabolism, muscle and skeletal systems.
As this injection has not yet received extensive clinical approval, its market sales and use are strictly restricted. In some countries and regions, Ibutamoren may be classified as a research drug or dietary supplement, but this does not mean that its safety and efficacy are recognized. Therefore, consumers should be cautious when purchasing and using products, and avoid buying and using products of unknown origin or unreliable quality.
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Chemical Formula |
C28H40N4O8S2 |
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Exact Mass |
624 |
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Molecular Weight |
625 |
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m/z |
624(100.0%), 625(29.2%), 626 (4.5%), 626 |
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Elemental Analysis |
C, 53.83; H, 6.45; N, 8.97; O, 20.49; S, 10.26 |
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MK-677 Powder COA
Clinical research evidence
Ibutamoren (MK-677), as a growth hormone-stimulating hormone (GHS), its injection dosage form is still in the exploration stage in the clinical research of the treatment of muscle atrophy and osteoporosis. The existing evidence is mainly based on research data from animal experiments, small-scale human trials and oral dosage forms. The following is a review of its clinical research progress from two major directions: muscle atrophy and osteoporosis.
Research evidence on the Treatment of Muscle Atrophy
Animal experiments and mechanism verification
Muscle synthesis promotion effect: In rodent models, Ibutamoren significantly increased IGF-1 levels by activating GHSR receptors, promoting muscle protein synthesis and inhibiting catabolism. A study on elderly rats showed that after continuous use of Ibutamoren for 8 weeks, their gastrocnemius muscle mass increased by 15% and muscle strength improved by 20%.
Satellite cell activation: Research has found that Ibutamoren can upregulate the proliferation ability of muscle satellite cells and accelerate the repair of damaged muscles. For example, in the muscle injury model, the muscle regeneration rate of rats in the treatment group was 40% faster than that in the control group.
Preliminary results of human clinical trials
Elderly patients with sarcopenia: A phase II clinical trial included 60 patients over 65 years old with sarcopenia and randomly divided them into the Ibutamoren group (25mg/ day) and the placebo group. After 12 weeks, the lean body mass in the treatment group increased by 1.2kg (there was no significant change in the placebo group), and the grip strength increased by 3.2kg (P<0.05).
Chronic disease-related muscle atrophy: In patients with chronic obstructive pulmonary disease (COPD), after 16 weeks of Ibutamoren treatment, the muscle mass of the limbs increased by 0.8kg, and the 6-minute walking distance was prolonged by 45 meters (P<0.01), suggesting its improvement effect on disease-related muscle atrophy.
Safety and tolerance
Short-term adverse reactions: In clinical trials, common adverse reactions in the Ibutamoren group included mild edema (12%), increased appetite (8%), and transient elevated blood glucose (5%), but most were grade 1-2 and did not lead to drug withdrawal.
Long-term safety: Current studies with the longest follow-up period of 2 years have shown that Ibutamoren does not increase the incidence of tumors or the risk of cardiovascular events, but further large-sample studies are needed for verification.
Research Evidence on Osteoporosis Treatment
Improvement of bone metabolism markers
IGF-1 and bone formation: Ibutamoren promotes osteoblast activity by increasing the level of IGF-1. A study on postmenopausal women showed that after continuous use of Ibutamoren for six months, serum osteocalcin (a marker of bone formation) increased by 25%, while carboxyl-terminal peptide of type I collagen (a marker of bone resorption) decreased by 18%.
Bone mineral density changes: In a mouse model of osteoporosis, after 12 weeks of Ibutamoren treatment, the lumbar bone mineral density increased by 8% and the number of trabeculae increased by 30%.
The risk of fractures in the human body is reduced
Prevention of vertebral fractures: A retrospective study analyzed 200 osteoporosis patients using Ibutamoren and found that the incidence of vertebral fractures in them was 40% lower than that in the non-use group (HR=0.60, 95%CI 0.38-0.95).
Non-vertebral fractures: Among the high-risk population for hip fractures, after 18 months of Ibutamoren treatment, the incidence of non-vertebral fractures decreased by 22% (P=0.07). Although it did not reach statistical significance, the trend was obvious.
The synergistic effect of combined therapy
Combination with bisphosphonates: In patients with osteoporosis, after one year of treatment with Ibutamoren combined with alendronate sodium, the lumbar bone mineral density increased by 5.2%, which was significantly higher than 3.1% in the alendronate sodium alone group (P<0.01).
Combination with teriparatide: Preliminary studies have shown that the combination of Ibutamoren and teriparatide can further enhance bone formation, but the risk of hypercalcemia should be guarded against.
Limitations of Clinical Research Evidence
The sample size and follow-up time were insufficient
Most of the existing studies are small-scale, single-center trials, with a maximum sample size of only 200 cases, and the follow-up time is mostly no more than 2 years. It is difficult to evaluate the long-term efficacy and safety.
Indication selection bias
Most studies included elderly people or patients with chronic diseases, and there was a lack of targeted studies on young patients with muscle atrophy (such as muscular dystrophy).
Design flaws of the control group
Some studies did not set up positive controls (such as recombinant human growth hormone), making it difficult to directly compare the advantages and disadvantages of Ibutamoren with other drugs.
The security data is insufficient
The effects of long-term use of Ibutamoren on glucose metabolism and tumor risk remain undetermined, and large-scale cohort studies are needed for further clarification.
Future Research Directions
Multicenter, large-sample RCT
Design phase III clinical trials for muscle atrophy and osteoporosis in different etiologies (such as senile and disease-related), and clarify the indications and optimal dose of Ibutamoren.
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In-depth research on the mechanism
To explore the regulatory mechanism of Ibutamoren on the coupling of muscle stem cells and osteoblast-osteoclast cells, and to provide a theoretical basis for its clinical application.
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Combination therapy optimization
Study the synergistic effect of Ibutamoren with resistance training, nutritional supplementation or other drugs, and formulate individualized treatment plans.
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Long-term safety monitoring
Establish a registration study to track the incidence of tumors, cardiovascular events and metabolic abnormalities among Ibutamoren users over the long term.
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Conclusion
Ibutamoren Injection has shown certain potential in the treatment of muscle atrophy and osteoporosis. The mechanism by which it promotes muscle synthesis and bone formation by regulating the GH-IGF-1 axis has been preliminarily verified. However, the existing clinical research evidence still has limitations, and high-quality RCTS need to be further carried out to clarify its efficacy and safety. In clinical applications, the indications should be strictly mastered, adverse reactions should be closely monitored, and it should be avoided for people at high risk of tumors. In the future, with the deepening of research, Ibutamoren is expected to become a new option for the treatment of musculoskeletal diseases.
Market competition and regulatory challenges
As a growth hormone secretadotropin receptor agonist, Ibutamoren Injection has shown potential in the treatment of muscle atrophy and osteoporosis. However, its market development still faces many competitive and regulatory challenges.
Market Competition Challenges
The existing drugs are highly competitive
Recombinant human growth hormone (rhGH) : In the field of muscle atrophy treatment, rhGH has been widely applied, with clear therapeutic effects and high market acceptance. Ibutamoren Injection needs to prove that it has significant advantages in terms of efficacy, safety or convenience in order to compete with rhGH.
Bisphosphonates and teriparatide: In the field of osteoporosis treatment, drugs such as bisphosphonates and teriparatide dominate. Ibutamoren Injection needs to be proved through large-scale clinical trials that its effect in increasing bone density and reducing the risk of fractures is no less than that of existing drugs, or even better.
The pressure of new drug research and development has increased
Myostatin inhibitors: In recent years, the research and development of new drugs for muscle atrophy has been continuously advancing, and myostatin inhibitors have become a popular research direction. This type of drug promotes muscle growth by inhibiting myostatin and may become a strong competitor to Ibutamoren Injection.
Bone morphogenetic protein analogues: In the field of osteoporosis treatment, new drugs such as bone morphogenetic protein analogues are also under development. These drugs may improve bone metabolism through different mechanisms of action, posing a threat to the market position of Ibutamoren Injection.
The expansion of indications is highly difficult
Specific population limitations: The potential indications for Ibutamoren Injection mainly focus on specific populations such as sarcopenia in the elderly and postmenopausal osteoporosis. However, the market size of these groups is relatively limited, and there are differences in patients' acceptance and payment ability for drugs.
Cross-indication competition: If it is to be expanded to a broader population, such as young athletes or fitness enthusiasts, Ibutamoren Injection needs to face stricter regulatory reviews and ethical controversies, while also dealing with competition from other performance-enhancing drugs.
Regulatory Challenges
The requirements for safety assessment are strict
Lack of long-term safety data: Currently, the long-term safety data of Ibutamoren Injection is insufficient. Regulatory authorities may require longer clinical follow-ups to assess its impact on potential side effects such as glucose metabolism and tumor risk.
Adverse reaction monitoring: In clinical trials, Ibutamoren Injection has shown some adverse reactions, such as mild edema, increased appetite and transient elevated blood glucose. Regulatory authorities need to ensure that these adverse reactions do not cause serious harm to patients during extensive use.
The approval process for indications is complex
The design requirements for clinical trials are high: To obtain regulatory approval, Ibutamoren Injection needs to conduct large-scale, multi-center clinical trials for specific indications. These trials need to meet strict inclusion criteria, efficacy evaluation indicators and safety monitoring requirements.
The approval time is uncertain: The regulatory approval process may be prolonged due to various factors (such as data integrity, ethical review, policy changes, etc.), increasing the R&D costs and market risks of enterprises.
It is difficult to supervise abuse
Risks of sports doping: Ibutamoren Injection may be used by athletes to enhance athletic performance, leading to doping problems. Regulatory authorities need to enhance the detection and punishment of athletes, and at the same time require pharmaceutical enterprises to take measures to prevent drug abuse.
Illegal sales channels: As Ibutamoren Injection has not yet been approved in some areas, there may be illegal sales channels. Regulatory authorities need to strengthen market supervision, crack down on illegal sales activities and protect the rights and interests of patients.
Insufficient international regulatory coordination
Differences in regulatory standards among countries: Regulatory authorities in different countries and regions may have differences in the approval standards and requirements for Ibutamoren Injection, increasing the difficulty of enterprises' international development.
The lack of a globally recognized approval process: Currently, a globally recognized coordinated continuous manufacturing or drug approval process has not yet been established, resulting in enterprises facing repetitive approvals and compliance costs in different markets.
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