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Panobinostat | CAS No: 404950-80-7 | GMP-certified suppliers
A medication that treats multiple myeloma in patients with prior therapies by improving progression-free survival when combined with dexamethasone and bortezomib.
Therapeutic categories
Primary indications
- Panobinostat is indicated in the treatment of multiple myeloma in combination with dexamethasone and bortezomib in patients who have received 2 previous treatment regimens including bortezomib and an immunomodulatory agent
- This indication is approved by accelerated approval based on progression free survival as of February 23, 2015
Product Snapshot
- Panobinostat is an oral small molecule formulated as capsules
- It is primarily used for the treatment of multiple myeloma in combination therapy after prior treatment regimens
- Panobinostat holds approved status in key regulatory markets including the US FDA and the EU
Clinical Overview
Pharmacologically, panobinostat is a non-selective, pan-HDAC inhibitor and is considered the most potent agent of its class on the market. It inhibits multiple histone deacetylase enzymes across class I (HDACs 1, 2, 3, 8), class II (HDACs 4, 5, 6, 7, 9, 10), and class IV (HDAC 11). These enzymes regulate acetylation status of numerous proteins involved in vital cellular processes such as DNA replication, repair, chromatin remodeling, gene transcription, cell cycle progression, protein degradation, and cytoskeletal dynamics. In multiple myeloma, overexpression of DAC proteins contributes to disease pathology, and panobinostat’s inhibition of these enzymes is believed to exert antitumor effects through epigenetic modulation and disruption of protein metabolism. Additionally, panobinostat has demonstrated cytotoxic synergy when combined with bortezomib, a proteasome inhibitor established in multiple myeloma therapy.
Regarding absorption, distribution, metabolism, and excretion (ADME), panobinostat is metabolized predominantly by cytochrome P450 enzymes, particularly CYP3A4, and is also a substrate for P-glycoprotein. It acts as a moderate inhibitor of CYP2D6. These interactions necessitate careful consideration of concomitant medications due to potential drug-drug interactions. Panobinostat has a narrow therapeutic index and carries a risk of QTc interval prolongation, warranting ECG monitoring during treatment. Safety concerns include hematologic toxicities, gastrointestinal events, and potential cardiac effects.
Panobinostat is marketed by Novartis under the brand name Farydak. Given its complex pharmacology and narrow therapeutic window, procurement of panobinostat API should ensure compliance with stringent quality standards, including verification of identity, purity, and consistent activity. Suppliers must provide comprehensive analytical data adhering to international regulatory expectations to support safe formulation and clinical use.
Identification & chemistry
| Generic name | Panobinostat |
|---|---|
| Molecule type | Small molecule |
| CAS | 404950-80-7 |
| UNII | 9647FM7Y3Z |
| DrugBank ID | DB06603 |
Pharmacology
| Summary | Panobinostat is a histone deacetylase (HDAC) inhibitor targeting class I, II, and IV HDAC enzymes, which regulate acetylation of numerous proteins involved in key cellular processes such as DNA repair, gene transcription, and cell cycle progression. Its pharmacological effect in multiple myeloma involves epigenetic modulation leading to altered gene expression and disruption of protein metabolism, contributing to antitumor activity. Panobinostat also enhances cytotoxic effects when combined with proteasome inhibitors like bortezomib. |
|---|---|
| Mechanism of action | Panobinostat is a deacetylase (DAC) inhibitor. DACs, also known as histone DACs (HDAC), are responsible for regulating the acetylation of about 1750 proteins in the body; their functions are involved in many biological processes including DNA replication and repair, chromatin remodelling, transcription of genes, progression of the cell-cycle, protein degradation and cytoskeletal reorganization. In multiple myeloma, there is an overexpression of DAC proteins. Panobinostat inhibits class I (HDACs 1, 2, 3, 8), class II (HDACs 4, 5, 6, 7, 9, 10) and class IV (HDAC 11) proteins. Panobinostat's antitumor activity is believed to be attributed to epigenetic modulation of gene expression and inhibition of protein metabolism. Panobinostat also exhibits cytotoxic synergy with bortezomib, a proteasome inhibitor concurrently used in treatment of multiple myeloma. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Histone deacetylase | Humans | inhibitor |
ADME / PK
| Absorption | After a 20 mg dose, panobinostat was quickly absorbed with a time to maximum absorption of 2 hours. |
|---|---|
| Half-life | 30 hours |
| Metabolism | Panobinostat was extensively metabolized to 77 metabolites. Unchanged panobinostat recovered in urine and feces was 2% and 3%, respectively. Primary metabolic pathways of panobinostat are reduction, hydrolysis, oxidation, and glucuronidation processes. CYP and non-CYP enzymes were found to play significant role in metabolism, CYP2D6 and CYP2C19 playing minor roles. |
Formulation & handling
- Panobinostat is a small molecule administered orally in capsule form due to its low water solubility and moderate lipophilicity.
- Avoid grapefruit and St. John's Wort during administration, as they respectively inhibit and induce CYP3A4 metabolism, impacting drug levels.
- Stable under standard handling conditions; dosing consistency and concurrent water intake are recommended to ensure reliable absorption.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is in a mature market phase in the US and EU following the expiration of multiple key patents in 2021, with additional patent protections extending until 2028 in the US. This staggered patent expiry supports ongoing product availability and potential generic competition in these regions. |
|---|
| Markets | EU, US |
|---|
Supply Chain
| Supply chain summary | Panobinostat is marketed under multiple branded products primarily in the US and EU markets. The presence of several active patents expiring between 2021 and 2028 indicates that while some patents have already expired, allowing for existing generic competition, other patents remain in effect, potentially limiting full generic market entry until their expiration. The originator companies play a key role in maintaining manufacturing and supply control through these patent protections. |
|---|
Safety
| Toxicity | Farydak carries a Boxed Warning alerting patients and health care professionals that severe diarrhea and severe and fatal cardiac events, arrhythmias and electrocardiogram (ECG) changes have occurred in patients receiving Farydak. Because of these risks, Farydak is being approved with a Risk Evaluation and Mitigation Strategy (REMS) consisting of a communication plan to inform health care professionals of these risks and how to minimize them. |
|---|
- Panobinostat exposure is associated with severe diarrhea and cardiac toxicity, including fatal arrhythmias and ECG changes
- Implementation of a REMS program addresses the risk of serious cardiac events in treated patients
- Close monitoring of cardiac parameters is recommended during handling to mitigate potential adverse effects
Panobinostat is a type of Protein kinase inhibitors
Protein kinase inhibitors are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in targeted cancer therapies. These inhibitors specifically target and block the activity of protein kinases, enzymes that regulate various cellular processes, including cell growth, division, and signal transduction.
Protein kinase inhibitors function by binding to the active site of protein kinases, preventing them from phosphorylating specific proteins and disrupting intracellular signaling pathways. This targeted approach inhibits the uncontrolled growth and proliferation of cancer cells, ultimately leading to their death.
The development of protein kinase inhibitors has revolutionized cancer treatment by providing more effective and less toxic alternatives to traditional chemotherapy. These drugs have demonstrated impressive results in the treatment of various cancers, including lung, breast, and leukemia.
The pharmaceutical industry invests heavily in research and development to discover novel protein kinase inhibitors with improved potency, selectivity, and pharmacokinetic properties. High-throughput screening, computational modeling, and structure-activity relationship studies are employed to identify potential lead compounds.
The success of protein kinase inhibitors in treating cancer has spurred significant interest in this subcategory of APIs. Ongoing research aims to expand their applications to other diseases, such as autoimmune disorders and neurological conditions.
In conclusion, protein kinase inhibitors are a valuable class of pharmaceutical APIs with immense potential for targeted cancer therapies. Continued advancements in this field hold promise for improved treatment outcomes and enhanced patient care.
Panobinostat (Protein kinase inhibitors), 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.
Panobinostat API manufacturers & distributors
Compare qualified Panobinostat API suppliers worldwide. We currently have 2 companies offering Panobinostat 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 |
|---|---|---|---|---|---|
| MSN Labs. | Producer | India | India | CoA, USDMF | 119 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
When sending a request, specify which Panobinostat 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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