Chidamide Tablets

Chidamide

Drug Description

Chidamide is an oral histone deacetylase (HDAC) inhibitor used for the treatment of specific types of cancers. It primarily targets peripheral T-cell lymphomas (PTCL) and other hematologic malignancies. By selectively inhibiting HDAC enzymes, Chidamide can regulate gene expression, inducing cell cycle arrest and promoting apoptosis in malignant cells.

Composition Details

Chidamide is chemically classified as a benzamide derivative. The active ingredient is Chidamide, with the molecular formula C22H19FN4O2. Inactive ingredients may vary depending on the formulation and manufacturer.

Clinical Trials

Chidamide has undergone various clinical trials to assess its efficacy and safety. Notable studies include:

  • Phase II Trial: Evaluated Chidamide in relapsed or refractory PTCL patients, demonstrating significant overall response rates.
  • Combination Therapy Trials: Investigated its use alongside other chemotherapeutic agents for synergistic effects.
  • Global Studies: Ongoing trials are assessing Chidamide’s role in solid tumors and other lymphomas.

Full Prescribing Information

Patients are advised to use Chidamide under the supervision of a qualified oncologist. Prescribing information includes dosage instructions, administration methods, and necessary safety precautions.

Indications and Contraindications

Indications:

Relapsed or refractory Peripheral T-cell Lymphoma (PTCL)

Certain cases of non-Hodgkin lymphoma (NHL)

Contraindications:

Severe hepatic impairment

Known hypersensitivity to Chidamide or its components

Pregnancy and breastfeeding

Side Effects and Interactions

Common Side Effects:

  • Fatigue
  • Nausea
  • Thrombocytopenia
  • Anemia

Serious Side Effects:

  • Severe infections
  • Hemorrhage
  • Cardiac complications

 

Drug Interactions:

  • CYP3A4 inhibitors or inducers may affect Chidamide’s metabolism.
  • Anticoagulants may increase bleeding risk.

 

Dosage Forms and Packaging

Chidamide is available in tablet form, typically as 10 mg or 20 mg tablets. Packaging may vary by manufacturer but is generally provided in blister packs or bottles to ensure stability.

Storage Conditions

Store Chidamide at 20°C to 25°C (68°F to 77°F).

Protect from moisture and light.

Keep out of reach of children.

Clinical Trials

Chidamide has undergone various clinical trials to assess its efficacy and safety. Notable studies include:

  • Phase II Trial: Evaluated Chidamide in relapsed or refractory PTCL patients, demonstrating significant overall response rates.
  • Combination Therapy Trials: Investigated its use alongside other chemotherapeutic agents for synergistic effects.
  • Global Studies: Ongoing trials are assessing Chidamide’s role in solid tumors and other lymphomas.

Regulatory Information

Chidamide has been approved for use in China by the National Medical Products Administration (NMPA). It has also received recognition in several other countries for the treatment of hematologic cancers.

Manufacturer Information

Chidamide is manufactured by Chipscreen Biosciences in China. The company is known for its research in small molecule drugs targeting cancer and other diseases.

Unique Identifiers

  • CAS Number: 743420-02-2
  • DrugBank ID: DB12259
  • UNII: 5MLG7E8BPQ

Public Data and Accessibility

Clinical trial data and additional research findings on Chidamide are accessible through platforms like:

  • ClinicalTrials.gov
  • PubMed
  • World Health Organization (WHO)

Self Certificates and Updates

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