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Ingenol mebutate | CAS No: 75567-37-2 | GMP-certified suppliers
A medication that provides topical treatment for actinic keratosis by promoting targeted cellular death to clear premalignant skin lesions effectively.
Therapeutic categories
Primary indications
- For the topical treatment of actinic keratosis
Product Snapshot
- Ingenol mebutate is formulated as a topical gel for cutaneous application
- It is primarily indicated for the treatment of actinic keratosis
- The product is approved for use in the EU, Canada, and the US regulatory markets
Clinical Overview
Pharmacodynamically, the precise process by which ingenol mebutate induces lesion clearance in actinic keratosis has not been fully elucidated. The leading hypothesis suggests that it triggers primary necrosis of targeted skin cells, followed by a neutrophil-mediated inflammatory response and antibody-dependent cellular cytotoxicity against lingering diseased keratinocytes.
At the molecular level, ingenol mebutate functions as a selective activator of protein kinase C (PKC). It preferentially activates PKC-delta, resulting in its translocation to the nucleus and cellular membranes. Concurrently, the compound downregulates PKC-alpha expression and activity. These effects modulate downstream signaling pathways including Ras/Raf/mitogen-activated protein kinase (MAPK), p38 MAPK activation, and inhibition of the AKT/protein kinase B (PKB) pathway. The coordinated impact on these signaling cascades likely contributes to the induction of cellular events culminating in increased cellular death.
Additional pharmacological activities have been noted in investigational contexts, including potent pro-apoptotic effects in myeloid leukemia cell lines at nanomolar concentrations; however, these are not established indications for therapeutic use.
Key absorption, distribution, metabolism, and excretion (ADME) properties relevant to topical application remain limited in the literature. Systemic exposure after topical use is generally minimal due to localized administration.
Safety considerations include localized skin reactions such as erythema, irritation, and pain at the application site. No significant systemic toxicities have been reported in approved usage. Monitoring for hypersensitivity reactions is advised.
Given its plant-derived origin from Euphorbia peplus sap, quality control and batch consistency are critical for active pharmaceutical ingredient (API) procurement. Sourcing should ensure rigorous purity specifications and verification of chemical identity to maintain therapeutic consistency and regulatory compliance.
Identification & chemistry
| Generic name | Ingenol mebutate |
|---|---|
| Molecule type | Small molecule |
| CAS | 75567-37-2 |
| UNII | 7686S50JAH |
| DrugBank ID | DB05013 |
Pharmacology
| Summary | Ingenol mebutate is a topical agent indicated for actinic keratosis that modulates protein kinase C isoforms, specifically activating PKC-delta and downregulating PKC-alpha. This modulation influences signaling pathways including Ras/Raf/MAPK, p38 activation, and AKT inhibition, leading to primary necrosis and neutrophil-mediated inflammatory responses. The combined effects contribute to the localized cell death of abnormal keratinocytes. |
|---|---|
| Mechanism of action | The exact mechanism of action of ingenol mebutate in actinic keratosis is unknown. It is presumed to involve primary necrosis then neutrophil-mediated inflammation and antibody-dependent cell death of residual disease cells. Additionally in early studies, PEP005 was shown to be an effective activator of PKC-delta and PKC-delta translocation into nucleus and membranes. PEP005 also downregulates the expression and activity of PKC-alpha. PEP005 induced modulation of PKCs leads to Ras/Raf/MAPK and p38 activation and AKT/PKB inhibition. |
| Pharmacodynamics | The pharmacodynamics of ingenol mebutate in producing cell death in actinic keratosis is unknown. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Protein kinase C delta type | Humans | ligand |
| Protein kinase C alpha type | Humans | ligand |
ADME / PK
| Absorption | Since ingenol mebutate is a topical treatment, the systemic absorption is less than 0.1 ng/mL. |
|---|---|
| Half-life | There is no half-life quantity since ingenol mebutate is a topical treatment. |
| Protein binding | There is no plasma protein binding quantity since ingenol mebutate is a topical treatment |
| Metabolism | There is no metabolism of Picato since ingenol mebutate is a topical treatment, and ingenol mebutate does not inhibit or induce a majority of the cytochrome P450 (CYP) enzymes. |
| Route of elimination | There is no route of elimination since ingenol mebutate is a topical treatment. |
| Volume of distribution | There is no volume of distribution quantity since ingenol mebutate is a topical treatment. |
| Clearance | There is no clearance quantity since ingenol mebutate is a topical treatment. |
Formulation & handling
- Ingenol mebutate is a small molecule formulated primarily for topical and cutaneous application as a gel.
- The API exhibits low water solubility and moderate lipophilicity (LogP 2.51), requiring appropriate formulation strategies for skin penetration.
- No specific food interaction concerns are noted, and systemic administration routes are not applicable for this compound.
Regulatory status
| Lifecycle | The API is marketed in the EU, Canada, and the US, with key patents in Canada and the US expiring in 2018, indicating market entry of generic products in these regions; additional US patents protect the API until late 2026, suggesting extended market exclusivity in the US. |
|---|
| Markets | EU, Canada, US |
|---|
Supply Chain
| Supply chain summary | Ingenol mebutate is marketed under several branded products, primarily in the EU, Canada, and the US. The patent landscape indicates multiple granted patents in the US and Canada, with key patents expiring between 2018 and 2026. The presence of patents expiring as recently as 2026 suggests existing or imminent opportunities for generic competition in these markets. |
|---|
Safety
| Toxicity | The most common adverse reactions are local skin reactions at the application site, headache, periorbital edema,and nasopharyngitis. |
|---|
- May cause local skin irritation upon contact
- Use protective equipment to minimize exposure
- Potential for respiratory tract irritation
Ingenol Mebutate is a type of Dermatics
Dermatics is a prominent subcategory within the pharmaceutical Active Pharmaceutical Ingredient (API) sector. It focuses on the development and production of APIs specifically designed for dermatological applications. These APIs play a crucial role in the formulation of various pharmaceutical products used in the treatment of skin disorders, including creams, ointments, gels, and lotions.
Dermatics APIs are meticulously developed to address specific dermatological conditions such as acne, psoriasis, eczema, fungal infections, and other related ailments. The APIs used in these formulations are carefully selected for their therapeutic efficacy, safety, and compatibility with the skin.
Manufacturers of Dermatics APIs employ rigorous quality control measures to ensure the purity, potency, and stability of their products. These APIs undergo extensive testing to meet stringent regulatory standards and pharmacopoeial guidelines. Additionally, the production processes adhere to Good Manufacturing Practices (GMP) to guarantee consistent quality and minimize the risk of contamination.
With the increasing demand for advanced dermatological treatments, Dermatics APIs are subject to continuous research and development. Newer APIs are being explored to enhance efficacy, minimize side effects, and improve patient compliance. The field of Dermatics APIs is characterized by innovation, as researchers strive to develop novel compounds and delivery systems that address unmet therapeutic needs.
In summary, Dermatics APIs are a vital component of pharmaceutical formulations used in the treatment of skin disorders. They undergo stringent quality control measures and are constantly evolving to provide effective and safe dermatological solutions.
Ingenol Mebutate (Dermatics), classified under Dermatological Agents
Dermatological agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the formulation of various skincare and dermatology products. These APIs are specifically designed to target and treat skin conditions, offering effective solutions for a wide range of dermatological concerns.
Dermatological agents encompass a diverse array of compounds, including corticosteroids, antifungal agents, antibacterials, retinoids, and immunomodulators. Each API within this category possesses unique properties and mechanisms of action, enabling them to address specific skin-related issues.
Corticosteroids, for instance, are potent anti-inflammatory agents commonly used in the treatment of skin conditions like eczema, psoriasis, and dermatitis. Antifungal agents, on the other hand, combat fungal infections such as athlete's foot or ringworm. Antibacterials are effective against bacterial infections, while retinoids promote skin cell turnover and treat acne and photoaging. Immunomodulators regulate the immune response, providing relief from conditions like atopic dermatitis.
The development and application of dermatological APIs involve rigorous research, clinical trials, and regulatory compliance. These APIs are typically integrated into topical creams, ointments, gels, and lotions, ensuring targeted delivery to the affected areas of the skin.
Dermatological agents play a crucial role in the management and treatment of various skin disorders. By harnessing the therapeutic properties of these APIs, pharmaceutical companies can develop innovative skincare products that cater to the diverse needs of individuals seeking effective dermatological solutions.
Ingenol Mebutate API manufacturers & distributors
Compare qualified Ingenol Mebutate API suppliers worldwide. We currently have 1 companies offering Ingenol Mebutate 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.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Indena | Producer | Italy | Unknown | CoA, GMP, USDMF | 15 products |
When sending a request, specify which Ingenol Mebutate 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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