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Idarubicin | CAS No: 58957-92-9 | GMP-certified suppliers
A medication that treats adult acute myeloid leukemia (AML) across all FAB subtypes, offering effective antineoplastic activity with a potentially reduced risk of cardiotoxicity.
Therapeutic categories
Primary indications
- For the treatment of acute myeloid leukemia (AML) in adults
- This includes French-American-British (FAB) classifications M1 through M7
Product Snapshot
- Idarubicin is available primarily as an injectable solution or lyophilized powder for intravenous administration, with some oral capsule formulations
- It is indicated for the treatment of acute myeloid leukemia (AML) in adults, encompassing French-American-British (FAB) classifications M1 through M7
- Idarubicin holds regulatory approval for use in the United States and Canada
Clinical Overview
Pharmacologically, idarubicin belongs to the anthracycline class, characterized by a tetracenequinone ring structure linked to a sugar moiety through glycosidic bonds. This compound exhibits cytotoxic effects primarily through intercalation into DNA, causing disruption of DNA function. It stabilizes the DNA-topoisomerase II complex, inhibiting the religation step of the topoisomerase II-mediated DNA cleavage-religation cycle, which ultimately leads to DNA strand breaks and apoptosis. In addition to topoisomerase II inhibition, idarubicin may interfere with DNA polymerase activity, influence gene expression regulation, and generate free radical-mediated DNA damage. Notably, idarubicin’s antitumor action is cell cycle-nonspecific, affecting both dividing and non-dividing cells.
Key ADME properties include metabolism primarily via hepatic cytochrome P450 enzymes, notably CYP2C9 and CYP2D6, which necessitates consideration of drug-drug interaction potential and variable patient metabolism. Idarubicin’s narrow therapeutic index requires careful dosing and monitoring to minimize toxicities.
Safety and toxicity concerns center on its myelosuppressive effects and potential cardiotoxicity, although the latter appears reduced relative to other anthracyclines such as doxorubicin. Monitoring of cardiac function is recommended during treatment. Other toxicities include mucositis, gastrointestinal disturbances, and risk of secondary malignancies.
Idarubicin is marketed under various brand names globally and is generally used within established chemotherapy regimens for AML. Given its complex synthesis and sensitivity to degradation, sourcing high-purity API from manufacturers compliant with international GMP standards is critical. Analytical verification of identity, purity, residual solvents, and stability profiles should guide procurement to ensure formulation consistency and regulatory compliance.
Identification & chemistry
| Generic name | Idarubicin |
|---|---|
| Molecule type | Small molecule |
| CAS | 58957-92-9 |
| UNII | ZRP63D75JW |
| DrugBank ID | DB01177 |
Pharmacology
| Summary | Idarubicin is an anthracycline antineoplastic agent targeting DNA and topoisomerase II-alpha. It exerts cytotoxic effects by intercalating into DNA and stabilizing DNA-topoisomerase II complexes, thereby inhibiting DNA religation and inducing strand breaks. This mechanism disrupts DNA replication and transcription, resulting in antitumor activity primarily for acute myeloid leukemia. |
|---|---|
| Mechanism of action | Idarubicin has antimitotic and cytotoxic activity through a number of proposed mechanisms of action: Idarubicin forms complexes with DNA by intercalation between base pairs, and it inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, preventing the religation portion of the ligation-religation reaction that topoisomerase II catalyzes. |
| Pharmacodynamics | Idarubicin is an antineoplastic in the anthracycline class. General properties of drugs in this class include: interaction with DNA in a variety of different ways including intercalation (squeezing between the base pairs), DNA strand breakage and inhibition with the enzyme topoisomerase II. Most of these compounds have been isolated from natural sources and antibiotics. However, they lack the specificity of the antimicrobial antibiotics and thus produce significant toxicity. The anthracyclines are among the most important antitumor drugs available. Doxorubicin is widely used for the treatment of several solid tumors while daunorubicin and idarubicin are used exclusively for the treatment of leukemia. Idarubicin may also inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to DNA. Idarubicin possesses an antitumor effect against a wide spectrum of tumors, either grafted or spontaneous. The anthracyclines are cell cycle-nonspecific. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA | Humans | intercalation |
| DNA topoisomerase 2-alpha | Humans | inhibitor |
ADME / PK
| Half-life | 22 hours |
|---|---|
| Protein binding | 97% |
| Route of elimination | The drug is eliminated predominately by biliary and to a lesser extent by renal excretion, mostly in the form of idarubicinol. |
Formulation & handling
- Idarubicin is available for both intravenous injection and oral administration, necessitating appropriate formulation for each route.
- As a small molecule anthracycline with moderate water solubility, it requires careful handling to maintain stability in solution, especially in lyophilized powder form.
- Handling precautions should address the cytotoxic nature of the compound, with storage conditions optimized to minimize degradation.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) has entered the mature phase of its lifecycle in both the US and Canadian markets following patent expiry. This has led to increased availability of generic versions and a stabilized competitive landscape. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Idarubicin is manufactured by several originator and generic companies, with multiple packagers involved in its distribution. Branded products are primarily present in the US and Canada markets, including various dosages of Idamycin. Patent expiry status indicates the availability of existing generic competition in these regions. |
|---|
Idarubicin is a type of Anthracycline Derivatives
Anthracycline derivatives are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs). These compounds are structurally derived from anthracyclines, which are natural antibiotics produced by certain strains of Streptomyces bacteria. Anthracycline derivatives exhibit potent anticancer properties and are commonly used in the treatment of various types of cancer, including breast cancer, leukemia, and lymphomas.
These APIs exert their therapeutic effects by interfering with the DNA replication process in cancer cells. They inhibit the activity of topoisomerase enzymes, which are responsible for unwinding and rewinding DNA strands during replication. By disrupting this process, anthracycline derivatives prevent cancer cells from dividing and multiplying, ultimately leading to their death.
Doxorubicin and daunorubicin are two well-known examples of anthracycline derivatives. These drugs have demonstrated remarkable efficacy in the treatment of cancer and are considered key components of chemotherapy regimens. However, their clinical use is limited by potential side effects, including cardiotoxicity and myelosuppression.
Despite these challenges, anthracycline derivatives continue to play a crucial role in oncology due to their proven efficacy against various types of cancer. Ongoing research aims to develop modified derivatives with reduced toxicity and enhanced therapeutic benefits. By harnessing the potential of these APIs, researchers and pharmaceutical companies strive to improve cancer treatment outcomes and enhance patient well-being.
Idarubicin (Anthracycline Derivatives), 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.
Idarubicin API manufacturers & distributors
Compare qualified Idarubicin API suppliers worldwide. We currently have 3 companies offering Idarubicin 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 |
|---|---|---|---|---|---|
| Synbias Pharma | Producer | Switzerland | Switzerland | CoA, USDMF | 7 products |
| Zhejiang Changming | Producer | China | China | CoA, WC | 19 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF, WC | 69 products |
When sending a request, specify which Idarubicin 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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