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Vorinostat | CAS No: 149647-78-9 | GMP-certified suppliers
A medication that treats progressive or recurrent cutaneous T‑cell lymphoma manifestations in patients previously exposed to multiple systemic therapies, supporting reliable oncology API sourcing.
Therapeutic categories
Primary indications
- For the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies
Product Snapshot
- Oral small‑molecule API supplied as capsules
- Used for cutaneous manifestations associated with cutaneous T‑cell lymphoma after prior systemic therapies
- Approved in the US and Canada, with additional investigational activity in other markets
Clinical Overview
Vorinostat is an inhibitor of Class I HDACs 1, 2, and 3 and the Class II enzyme HDAC6 at nanomolar concentrations. HDAC inhibition increases histone acetylation, leading to chromatin relaxation and modulation of gene expression. In malignant cells characterized by excessive HDAC activity or aberrant recruitment of these enzymes to oncogenic transcription factors, vorinostat can promote cell cycle arrest and apoptosis. The precise antineoplastic mechanism has not been fully defined, but epigenetic modulation is considered central to its activity.
Absorption, distribution, metabolism, and excretion data are not included here; therefore, only general principles apply. Vorinostat is administered systemically and is known to undergo metabolic clearance, but detailed kinetic parameters should be referenced from validated primary sources when required for formulation or regulatory assessments.
Safety considerations include risks of myelosuppression, gastrointestinal intolerance, hyperglycemia, dehydration, thromboembolic events, and QTc prolongation. Monitoring of blood counts, metabolic parameters, and cardiac risk factors is standard. Vorinostat is classified among narrow therapeutic index drugs, which necessitates careful dose management and evaluation of interacting agents. Its enzymatic target profile also places it within multiple pharmacological categories, including antineoplastic agents, enzyme inhibitors, hydroxamic acids, and immunomodulatory agents.
Vorinostat is marketed in some regions under the brand name Zolinza. For API procurement, sourcing should prioritize manufacturers with demonstrated control of impurity profiles, validated processes for handling hydroxamic acid functionalities, and complete regulatory documentation to support global development and supply chain traceability.
Identification & chemistry
| Generic name | Vorinostat |
|---|---|
| Molecule type | Small molecule |
| CAS | 149647-78-9 |
| UNII | 58IFB293JI |
| DrugBank ID | DB02546 |
Pharmacology
| Summary | Vorinostat is a histone deacetylase inhibitor that targets class I HDACs (HDAC1, HDAC2, HDAC3) and class II HDAC6 at nanomolar potency. Inhibition of these enzymes increases histone acetylation, altering chromatin structure and gene expression in malignant cells. These changes can promote cell cycle arrest and apoptosis, though the full antineoplastic mechanism is not completely defined. |
|---|---|
| Mechanism of action | Vorinostat inhibits the enzymatic activity of histone deacetylases HDAC1, HDAC2 and HDAC3 (Class I) and HDAC6 (Class II) at nanomolar concentrations (IC<sub>50</sub>< 86 nM). These enzymes catalyze the removal of acetyl groups from the lysine residues of histones proteins. In some cancer cells, there is an overexpression of HDACs, or an aberrant recruitment of HDACs to oncogenic transcription factors causing hypoacetylation of core nucleosomal histones. By inhibiting histone deacetylase, vorinostat causes the accumulation of acetylated histones and induces cell cycle arrest and/or apoptosis of some transformed cells. The mechanism of the antineoplastic effect of vorinostat has not been fully characterized. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Histone deacetylase 1 | Humans | inhibitor |
| Histone deacetylase 2 | Humans | inhibitor |
| Histone deacetylase 3 | Humans | inhibitor |
ADME / PK
| Half-life | 2 hours |
|---|---|
| Protein binding | 71% |
| Metabolism | The major pathways of vorinostat metabolism involve glucuronidation and hydrolysis followed by β-oxidation. Human serum levels of two metabolites, O-glucuronide of vorinostat and 4-anilino-4-oxobutanoic acid were measured. Both metabolites are pharmacologically inactive. Compared to vorinostat, the mean steady state serum exposures in humans of the O-glucuronide of vorinostat and 4-anilino-4-oxobutanoic acid were 4-fold and 13-fold higher, respectively. In vitro studies using human liver microsomes indicate negligible biotransformation by cytochromes P450 (CYP). |
| Route of elimination | In vitro studies using human liver microsomes indicate negligible biotransformation by cytochromes P450 (CYP). Vorinostat is eliminated predominantly through metabolism with less than 1% of the dose recovered as unchanged drug in urine, indicating that renal excretion does not play a role in the elimination of vorinostat. However, renal excretion does not play a role in the elimination of vorinostat. |
Formulation & handling
- Oral small‑molecule solid with low aqueous solubility, suggesting need for solubility‑enhancing or dissolution‑rate–improving formulation strategies.
- Bioavailability is food‑sensitive, so formulation and labeling should account for increased exposure when administered with food.
- Chemically stable aromatic hydroxamate derivative; standard solid‑state handling is adequate, with attention to controlling moisture due to limited solubility.
Regulatory status
| Lifecycle | Most foundational U.S. and Canadian patents have expired, with the remaining U.S. protection ending in February 2025, indicating a late‑lifecycle product. In the US and Canada, the API is positioned for full generic competition as remaining exclusivity concludes. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Vorinostat is supplied primarily through the originator company with packaging support from contract manufacturers, and its branded product is distributed in the US and Canada. Market presence appears limited to North America, with no major EU listings indicated. Most key patents have expired, and the remaining US protection ends in 2025, suggesting that generic competition is emerging or likely in the near term. |
|---|
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Vorinostat is a type of Cytostatic antibiotics
Cytostatic antibiotics are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the treatment of various types of cancer. These antibiotics possess powerful cytostatic or cell-inhibiting properties, which impede the growth and division of cancer cells.
Cytostatic antibiotics work by selectively targeting and inhibiting specific enzymes and proteins necessary for the replication and proliferation of cancer cells. By interrupting these vital cellular processes, these APIs effectively hinder the progression of cancer and prevent the spread of malignant cells.
One prominent example of a cytostatic antibiotic is Doxorubicin, which belongs to the anthracycline class of antibiotics. Doxorubicin functions by intercalating with DNA molecules, preventing DNA replication and inhibiting the activity of topoisomerase enzymes. These mechanisms effectively impede the growth and division of cancer cells.
Another commonly used cytostatic antibiotic is Mitomycin C. It exerts its anticancer effects by inducing DNA cross-linking, leading to the inhibition of DNA synthesis and cell division. This antibiotic is particularly effective against a variety of solid tumors.
Cytostatic antibiotics are administered in different ways, such as intravenous injection or oral consumption, depending on the specific drug. These APIs are often used in combination with other chemotherapy agents or treatment modalities to achieve optimal therapeutic outcomes.
In conclusion, cytostatic antibiotics are a vital subcategory of pharmaceutical APIs used in cancer treatment. Their ability to inhibit cell growth and division makes them essential in combating various types of cancer, ultimately improving patient outcomes.
Vorinostat (Cytostatic antibiotics), classified under Anticancer drugs
Anticancer drugs belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category designed specifically to combat cancer cells. These powerful medications play a crucial role in cancer treatment and are developed to target and destroy cancerous cells, preventing their growth and spread.
Anticancer drugs are classified based on their mode of action and can include various types such as chemotherapy drugs, targeted therapy drugs, immunotherapy drugs, and hormonal therapy drugs. Chemotherapy drugs work by interfering with the cell division process, thereby inhibiting the growth of cancer cells. Targeted therapy drugs, on the other hand, are designed to attack specific molecules or genes involved in cancer growth, minimizing damage to healthy cells. Immunotherapy drugs stimulate the body's immune system to recognize and destroy cancer cells. Hormonal therapy drugs are used in cancers that are hormone-dependent, such as breast or prostate cancer, to block the hormones that fuel cancer cell growth.
These APIs are typically synthesized through complex chemical processes in state-of-the-art manufacturing facilities. Stringent quality control measures ensure the purity, potency, and safety of these drugs. Anticancer APIs undergo rigorous testing and adhere to stringent regulatory guidelines before being approved for clinical use.
Due to their critical role in cancer treatment, anticancer drugs are in high demand worldwide. Researchers and pharmaceutical companies continually strive to develop new and more effective APIs in this category to enhance treatment outcomes and minimize side effects. The ongoing advancements in the field of anticancer drug development offer hope for improved cancer therapies and better patient outcomes.
Vorinostat API manufacturers & distributors
Compare qualified Vorinostat API suppliers worldwide. We currently have 2 companies offering Vorinostat API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Mylan | Producer | India | India | CoA, USDMF | 201 products |
When sending a request, specify which Vorinostat 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 Vorinostat 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.
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Technical
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