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Docosanol | CAS No: 661-19-8 | GMP-certified suppliers
A medication that provides topical antiviral treatment for recurrent oral-facial herpes simplex episodes, reducing healing time and symptoms of cold sores and fever blisters.
Therapeutic categories
Primary indications
- For the topical treatment of recurrent oral-facial herpes simplex episodes (cold sores or fever blisters)
Product Snapshot
- Docosanol is formulated as a topical cream for external application
- It is primarily indicated for the treatment of recurrent oral-facial herpes simplex infections
- Docosanol holds approved status in the US and Canada markets
Clinical Overview
Pharmacologically, docosanol exhibits antiviral activity primarily against lipid-enveloped viruses, including herpes simplex virus types 1 and 2. Its mechanism of action involves inhibition of the fusion process between the viral envelope and the host cell plasma membrane. By blocking this critical step, docosanol prevents viral entry into susceptible cells and subsequent replication. Unlike nucleoside or nucleotide analog antiviral agents, docosanol does not exert direct virucidal effects and thus is less likely to induce viral resistance mutations.
Clinically, docosanol is applied topically to lesions during the early stages of HSV outbreaks, where it has been shown to reduce healing time of cold sores and ameliorate symptoms such as tingling, pain, burning, and itching. It does not, however, have prophylactic efficacy in preventing recurrence or initial viral infection.
Absorption through intact skin is minimal given the intended topical route, resulting in limited systemic exposure. As a result, systemic pharmacokinetic parameters such as bioavailability and metabolism are not well-defined. Safety profiles indicate low toxicity with infrequent adverse reactions, mostly local skin irritation.
Docosanol is marketed under various brand names in multiple regulatory jurisdictions and is recognized within antiviral dermatological agents designed for episodic management of herpes simplex virus infections.
When sourcing docosanol active pharmaceutical ingredient (API), considerations include ensuring adherence to pharmacopeial standards for purity and identity, especially given its classification as a fatty alcohol which may be susceptible to oxidation or impurities during manufacture and storage. Reliable supply chains and quality control testing are essential to maintain consistency and compliance for topical antiviral formulations.
Identification & chemistry
| Generic name | Docosanol |
|---|---|
| Molecule type | Small molecule |
| CAS | 661-19-8 |
| UNII | 9G1OE216XY |
| DrugBank ID | DB00632 |
Pharmacology
| Summary | Docosanol is a saturated aliphatic alcohol that inhibits fusion between the host cell plasma membrane and the herpes simplex virus (HSV) envelope, preventing viral entry and replication. Its antiviral activity targets lipid-enveloped viruses, including HSV, by interfering with viral envelope glycoproteins. This mechanism reduces viral propagation without directly targeting viral components, minimizing the risk of drug resistance. |
|---|---|
| Mechanism of action | Docosanol works by inhibiting fusion between the human cell plasma membrane and the herpes simplex virus (HSV) envelope, thereby preventing viral entry into cells and subsequent viral replication. Unlike other cold-sore antivirals, docosanol does not act directly on the virus, and as such it is unlikely it will produce drug resistant mutants of HSV. |
| Pharmacodynamics | Docosanol is a saturated 22-carbon aliphatic alcohol which exhibits antiviral activity against many lipid enveloped viruses including herpes simplex virus (HSV). Docosanol speeds the healing of cold sores and fever blisters on the face or lips. It also relieves the accompanying symptoms, including tingling, pain, burning, and itching. Docosanol cannot, however, prevent cold sores or fever blisters from appearing. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Envelope glycoprotein GP350 | HHV-4 | intercalation |
| Envelope glycoprotein GP340 | HHV-4 | intercalation |
ADME / PK
| Absorption | Topical absorption has been shown to be minimal under conditions reflecting normal clinical use. |
|---|
Formulation & handling
- Docosanol is a small molecule fatty alcohol primarily formulated for topical administration due to its low water solubility and high lipophilicity (LogP 8.81). Its formulation as a cream facilitates local delivery to the skin, avoiding systemic exposure typical of oral or injectable routes. Handling considerations include maintaining stability in cream formulations to prevent degradation in a predominantly lipophilic environment.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient has surpassed patent expiration dates in both the United States and Canada, indicating market maturity and the potential availability of generic versions in these regions. Ongoing marketing activities are primarily focused in the US and Canadian markets. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Docosanol is primarily manufactured and packaged by a single originator company, GlaxoSmithKline, with branded products marketed mainly in the US and Canada. The presence of patents expiring as recently as 2019 and 2022 indicates potential for existing or near-term generic competition within these markets. The supply landscape is therefore characterized by a concentrated originator presence with emerging generic opportunities post-patent expiry. |
|---|
Safety
| Toxicity | Symptoms of overdose include headache, abdominal pain, increased serum lipase, nausea, dyspepsia, dizziness, and hyperbilirubinemia. |
|---|
- 1
- Exposure may cause gastrointestinal irritation and central nervous system effects such as dizziness and headache
- 2
Docosanol is a type of Antivirals
Antivirals are a crucial subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a pivotal role in combating viral infections. These specialized compounds are designed to inhibit the growth and replication of viruses within the human body.
Antivirals target various stages of the viral life cycle, including viral attachment, entry, and replication. They can interfere with viral enzymes, block viral receptors, or disrupt viral protein synthesis. By doing so, antivirals effectively suppress the viral infection, reduce symptoms, and improve patient outcomes.
The development of antiviral APIs requires extensive research and scientific expertise. Pharmaceutical companies employ cutting-edge technologies to identify potential antiviral compounds, screen their efficacy, and optimize their therapeutic properties. The most promising candidates undergo rigorous testing in preclinical and clinical trials to ensure their safety and effectiveness.
Antivirals have proven to be indispensable in the management of various viral infections, such as influenza, HIV, hepatitis B and C, herpes, and respiratory syncytial virus (RSV). They not only provide symptomatic relief but also prevent viral transmission and reduce the risk of complications.
With the ongoing global concern over emerging viral diseases and the impact of pandemics, the demand for effective antiviral therapies continues to rise. Pharmaceutical companies and researchers are actively exploring new avenues, such as broad-spectrum antivirals and novel drug delivery systems, to enhance the antiviral arsenal.
In conclusion, antiviral APIs are vital components of the pharmaceutical industry, offering hope in the fight against viral infections. Through continuous innovation and research, these substances contribute to improving public health by mitigating the impact of viral diseases.
Docosanol (Antivirals), classified under Anti-infective Agents
Anti-infective agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various infectious diseases. These agents play a crucial role in combating bacterial, viral, fungal, and parasitic infections. The demand for effective anti-infective APIs has grown significantly due to the increasing prevalence of drug-resistant microorganisms.
Anti-infective APIs encompass a wide range of substances, including antibiotics, antivirals, antifungals, and antiparasitics. Antibiotics are particularly important in fighting bacterial infections and are further categorized into different classes based on their mode of action and target bacteria. Antivirals are designed to inhibit viral replication and are essential in the treatment of viral infections such as influenza and HIV. Antifungals combat fungal infections, while antiparasitics are used to eliminate parasites that cause diseases like malaria and helminthiasis.
The development and production of high-quality anti-infective APIs require stringent manufacturing processes and adherence to regulatory standards. Pharmaceutical companies invest heavily in research and development to discover new and more effective anti-infective agents. Additionally, ensuring the safety, efficacy, and stability of these APIs is of utmost importance.
The global market for anti-infective APIs is driven by factors such as the rising incidence of infectious diseases, the emergence of new and drug-resistant pathogens, and the growing demand for improved healthcare infrastructure. Continuous advancements in pharmaceutical technology and the development of innovative drug delivery systems further contribute to the expansion of this market.
In conclusion, anti-infective agents are a critical category of pharmaceutical APIs that play a pivotal role in treating infectious diseases. Their effectiveness in combating various types of infections makes them essential components in the arsenal of modern medicine.
Docosanol API manufacturers & distributors
Compare qualified Docosanol API suppliers worldwide. We currently have 3 companies offering Docosanol 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 |
|---|---|---|---|---|---|
| Biophore India | Producer | India | India | CoA, USDMF | 46 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Maithri Drugs | Producer | India | India | CoA, USDMF | 12 products |
When sending a request, specify which Docosanol 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 Docosanol 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.
