PT-141 Injection (Bremer Wanda Injection) is a synthetic peptide-based drug in the form of white powder. Its molecular formula is C50H68N14O10 and it has significant applications in the medical field. As a melanocortin receptor agonist, it can non-selectively activate receptor subtypes such as MC1R and MC4R, and by regulating the release of neurotransmitters in the central nervous system (such as dopamine, norepinephrine, and oxytocin), it effectively enhances sexual desire and sexual ability. In 2019, the US FDA approved it for the treatment of sexual dysfunction in premenopausal women (HSDD), and it also showed significant efficacy for male erectile dysfunction (especially for those who do not respond to traditional drugs). This drug is administered by subcutaneous injection and is usually used 45 minutes before sexual activity. Its mechanism of action is related to promoting blood flow to the genital area and enhancing sexual arousal, providing new treatment options for patients with sexual dysfunction.
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PT-141 COA
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| Certificate of Analysis | ||
| Compound name | Bremelanotide/PT-141 | |
| CAS No. | 189691-06-3 | |
| Quantity | 35g | |
| Packaging standard | PE bag+Al foil bag | |
| Manufacturer | Shaanxi BLOOM TECH Co.,Ltd | |
| Lot No. | 20251005035 | |
| MFG | Oct.05th2025 | |
| EXP | Oct.05th2028 | |
| Structure |
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| Item | Enterprise standard | Analysis result |
| Appearance | White to off-white solid powder | Conformed |
| Water content | ≤5.0% | 0.25% |
| Loss on drying | ≤1.0% | 0.32% |
| Heavy Metals | Pb≤0.5ppm | N.D. |
| As≤0.5ppm | N.D. | |
| Hg≤0.5ppm | N.D. | |
| Cd≤0.5ppm | N.D. | |
| Purity (HPLC) | ≥99.0% | 99.10% |
| Single impurity | <0.8% | 0.23% |
| Total microbial count | ≤750cfu/g | 89 |
| E. Coli | ≤2MPN/g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (by GC) | ≤5000ppm | 400pm |
| Storage | Store in a sealed, dark, and dry place below 2-8°C | |
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| Chemical Formula | C50H68N14O10 |
| Exact Mass | 1024.52 |
| Molecular Weight | 1025.18 |
| m/z | 1024.52(100.0%),1025.53(54.1%),1026.53(14.3%),1025.52(5.2%),1026.52(2.8%),1026.53(2.1%),1027.53(1.7%),1027.53(1.1%) |
| Elemental Analysis | C,58,58;H,6.69;N,19.13;O,15.61 |
PT-141 Injection as an innovative drug, demonstrates unique value in the treatment of male erectile dysfunction (ED). Its application can be analyzed from the following perspectives:
Mechanism of Action: Central Regulation, Activation of Sexual Desire
PT-141 activates the melanocortin-4 receptor (MC4R) in the hypothalamus of the brain, triggering a neurochemical reaction chain, which directly stimulates sexual desire and arousal. This mechanism is fundamentally different from traditional ED drugs:
Traditional medicine: It improves local blood flow by dilating blood vessels, addressing "hardware" issues (such as erectile hardness or lubrication), and requires sexual stimulation to trigger.
PT-141: It bypasses the hormonal pathway and directly acts on the neural pathways related to motivation and reward, addressing "software" issues (such as loss of sexual desire or spontaneous thoughts).
Studies have shown that PT-141 can significantly prolong the duration of erections, and the effect is dose-dependent. In healthy individuals, even without visual sexual stimulation, the erectile response increases with the dose; for ED patients who do not respond well to sildenafil, the success rate of erections after subcutaneous administration of PT-141 significantly improves.
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Clinical advantages: Fill the gap in traditional treatment
Break through the limitation of vascular dependence
PT-141 does not act on the vascular system, avoiding the possible side effects such as headache, facial flushing, and abnormal vision caused by traditional medications, and is especially suitable for patients with cardiovascular diseases or those taking nitrate drugs.
Cover special ED populations
Psychogenic ED: For ED caused by psychological factors such as anxiety and depression, PT-141 directly improves sexual desire through central regulation, breaking the vicious cycle of "psychological burden - worsening of the condition".
Refractory ED: For patients who are ineffective or intolerant to PDE5 inhibitors, PT-141 provides an alternative solution. In clinical trials, some patients achieved "strong and frequent" erections after using PT-141, with a duration of 2-6 hours.
Suitable for both men and women
PT-141 is the first centrally-acting agent approved for the treatment of female hypoactive sexual desire disorder (HSDD), and it is one of the few ED treatment drugs that also caters to both male and female needs.
Safety and Precautions: Rigorous assessment, standardized use
Common side effects
Nausea (about 40% of patients), mostly mild to moderate, may decrease with the increase in the number of doses.
Facial flushing, headache, and injection site reactions, with a low incidence and controllable nature.
Contraindications and risks
Cardiovascular diseases: PT-141 may cause temporary blood pressure elevation and heart rate reduction. It is prohibited for patients with uncontrolled hypertension or cardiovascular diseases. The cardiovascular status needs to be evaluated before use, as ED may be a local manifestation of systemic atherosclerosis.
Long-term safety: Current data are mainly based on short-term clinical trials. Long-term use requires regular monitoring of side effects and efficacy.
Usage guidelines
Dosage and frequency: For females, the initial dose is 750μg - 1mg, no more than once within 24 hours, and no more than 8 times per month. For males, the dose needs to be adjusted according to individual responses, avoiding excessive dosing.
Injection timing: It is recommended to inject 45 minutes before sexual activity. The timing can be optimized based on the duration of side effects (such as the impact of nausea on the medication experience).
Regular assessment: Long-term use requires regular assessment of sexual function improvement and the risk of side effects, especially attention to cardiovascular health indicators.
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Market Positioning and Future Outlook
As the first centrally-acting ED treatment drug, PT-141 has opened up a new path in sexual medicine. Its advantages lie in:
Filling market gaps
Offering new options for patients who do not respond or cannot tolerate traditional medications, especially for those with psychological erectile dysfunction or those with co-occurring cardiovascular diseases.
Potential for combination therapy
Early trials have shown that the combination of PT-141 with sildenafil can significantly prolong the duration of erections without increasing health risks. Further exploration of more combination treatment options is possible in the future.
However, its promotion faces challenges:
Side effect management: The incidence of nausea is relatively high, which may affect medication adherence and needs to be addressed through dose adjustment or combination therapy.
Market education: It is necessary to clearly distinguish between "therapeutic drugs" and "entertainment drugs" to prevent abuse. Currently, there are non-pharmaceutical products labeled as "research chemicals" circulating on the market, which have uncontrolled quality and increase safety risks.
Medical scenario
PT-141 Injection demonstrates unique application value in medical scenarios. Its research and development process, drug form, usage method, and market positioning all reflect the innovation and precision of modern drug research.
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Research Background: An Unexpected Breakthrough from "Beauty" to "Therapy"
The discovery of PT-141 originated from an "unexpected" side effect. Scientists initially developed a peptide called Melanotan I, aiming to stimulate melanocyte-stimulating hormone to promote skin tanning and prevent skin cancer. However, during clinical trials, both researchers and participants reported a significant side effect - spontaneous sexual arousal and erection. This accidental discovery led the research in a completely new direction. Based on the structure of Melanotan I, the researchers developed a more active analogue, Melanotan II, but its side effects (such as nausea and facial flushing) were still obvious. After further optimization, the pro-sexual function activity was retained while reducing other side effects. Eventually, PT-141 was obtained and specifically developed for the treatment of female sexual desire disorders.
Drug Formulation and Specifications: Meeting the diverse needs of research and clinical applications
PT-141 is a synthetic cyclic heptapeptide. Its acetate form (PT-141 Acetate) is highly soluble in water, making it easy to prepare and inject. In medical settings, PT-141 is supplied in various specifications, including 1mg, 5mg, 10mg, 25mg, etc., to meet different research and clinical requirements. Its purity is typically above 95%, ensuring the stability and effectiveness of the drug. Additionally, the storage conditions for PT-141 are very strict, requiring it to be stored at -20℃ to prevent drug degradation and failure.
Usage: Precise injection, convenient and efficient
The usage method of PT-141 Injection is very convenient. It is usually administered by subcutaneous injection. The injection site can be chosen as the abdomen or the thigh. For female patients, it is recommended to inject at least 45 minutes before sexual activity to ensure that the drug is fully absorbed and takes effect. During the injection, patients can use an automatic injection pen, which is simple to operate and causes minimal pain. This precise injection method not only improves the utilization rate of the drug but also reduces unnecessary side effects and risks.
Market positioning: Filling the gap in female sexual desire disorder treatment
The market positioning of PT-141 Injection in the medical field is very clear. As the first and currently the only drug that mainly acts on the central nervous system to treat female sexual desire reduction disorders, it has filled the market gap. Based on the data from a large-scale, randomized, double-blind, placebo-controlled Phase III clinical trial, PT-141 has been approved for marketing by the US Food and Drug Administration (FDA) and is used to treat pre-menopausal women with acquired, comprehensive sexual desire reduction disorders. In addition, PT-141 has also been approved in Canada and other regions, providing new treatment options for patients worldwide.
Research Value: Promoting the Development of Medical Fields
Apart from its clinical applications, PT-141 also holds significant value in the field of research. As a melanocortin receptor agonist, it provides a new tool for studying physiological functions such as sexual arousal, appetite regulation, and skin pigmentation. Researchers can explore the mechanism of action of PT-141 to further understand the role of the central nervous system in sexual behavior regulation, thereby providing a theoretical basis for the development of new drugs for sexual dysfunction
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FAQ
1. What is PT-141 used for?
PT-141 (Bremelanotide) is a synthetic peptide used primarily to treat sexual dysfunction, boosting libido and arousal by acting on melanocortin receptors in the brain, helping both premenopausal women with HSDD (Hypoactive Sexual Desire Disorder) and men with erectile dysfunction, though often prescribed off-label for men, with benefits including increased desire, arousal, and mood enhancement, but requires medical consultation due to potential side effects like nausea, blood pressure changes, and fatigue.
2. Is PT-141 legal to buy?
PT-141 is approved by the FDA for hypoactive sexual desire disorder in premenopausal women and is not subjected to the categorization restrictions under Section 503A. It is not approved for treating sexual dysfunction in postmenopausal women or men.
3. How long does a PT-141 injection last?
Emotional Reconnection: Beyond the physical sensations, PT-141 fosters an emotional reconnection. You'll find yourself not only desiring your partner but also feeling more intimately connected on an emotional level. Long-Lasting Effects: The effects of PT-141 can last from six to 72 hours.
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