Mavacamten API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Mavacamten API

Mavacamten is an orally active cardiac myosin inhibitor used in the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). It selectively and reversibly reduces excessive cardiac myosin activity, helping decrease hypercontractility and improve cardiac function.

Mavacamten is a small-molecule pharmaceutical API and is marketed as an oral capsule.

Mavacamten API Manufacturer in India

Mavacamten is a specialized cardiovascular pharmaceutical API used in the development and manufacture of medicines for hypertrophic cardiomyopathy.

Key quality attributes include identity, assay, related substances, residual solvents, water content, elemental impurities, stereochemical purity and stability characteristics.

Chemical Information

CAS Number: 1642288-47-8
Molecular Formula: C15H19N3O2
Molecular Weight: 273.33 g/mol
Chemical Name: Mavacamten
Development Code: MYK-461
Drug Class: Cardiac Myosin Inhibitor
Therapeutic Class: Cardiovascular Agent
Therapeutic Area: Cardiology
Molecule Type: Synthetic Small Molecule

Mechanism of Action

Mavacamten is a selective, allosteric and reversible inhibitor of cardiac myosin ATPase.

It reduces the number of cardiac myosin heads available for interaction with actin, thereby decreasing excessive actin-myosin cross-bridge formation.

Its pharmacological effects include:

  • Reduction of excessive cardiac myosin activity
  • Decreased myocardial hypercontractility
  • Reduction in left ventricular outflow tract obstruction
  • Improvement in cardiac filling
  • Reduction of symptoms associated with obstructive HCM

Pharmaceutical Applications

Mavacamten API is used in pharmaceutical development for:

  • Obstructive hypertrophic cardiomyopathy
  • Symptomatic NYHA Class II–III obstructive HCM
  • Cardiovascular drug development
  • Cardiac myosin research
  • Hypertrophic cardiomyopathy research

Cardiovascular Applications

Mavacamten is primarily associated with obstructive hypertrophic cardiomyopathy, a condition characterized by excessive thickening of the heart muscle and, in some patients, obstruction of blood flow from the left ventricle.

By reducing excessive cardiac contractility, mavacamten can reduce left ventricular outflow tract obstruction and improve symptoms in appropriately selected patients.

Dosage Form Applications

Mavacamten is developed as an oral capsule.

Available capsule strengths include:

  • 2.5 mg
  • 5 mg
  • 10 mg
  • 15 mg

Physical Characteristics

Mavacamten is a synthetic small-molecule compound. Its physical and chemical characteristics should be controlled according to the applicable API specification, including purity, stereochemical composition and solid-state properties.

Manufacturing Process

A controlled Mavacamten API manufacturing process may involve:

  1. Selection and qualification of starting materials
  2. Preparation of key synthetic intermediates
  3. Controlled heterocyclic synthesis
  4. Formation of the required molecular framework
  5. Purification
  6. Crystallization
  7. Filtration
  8. Controlled drying
  9. Milling, where required
  10. Final analytical testing
  11. Pharmaceutical-grade packaging

Quality Control Testing

Typical Mavacamten API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Degradation products
  • Residual solvents
  • Water content
  • Elemental impurities
  • Chiral purity
  • Polymorphic form
  • Particle-size distribution where applicable
  • Stability testing

Storage

Store Mavacamten API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should follow the manufacturer's validated stability data.

Pharmaceutical Research

Mavacamten is relevant to research involving:

  • Cardiac myosin
  • Myosin ATPase
  • Hypertrophic cardiomyopathy
  • Left ventricular outflow tract obstruction
  • Cardiac contractility
  • Cardiovascular pharmacology
  • Small-molecule cardiovascular therapeutics
  • HCM drug development

Mavacamten API Summary

Mavacamten is an oral cardiac myosin inhibitor with CAS Number 1642288-47-8, molecular formula C15H19N3O2, and molecular weight 273.33 g/mol. It reduces excessive cardiac myosin activity and is primarily used for adults with symptomatic obstructive hypertrophic cardiomyopathy.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
pH (1% Solution) 4.0 – 6.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 2.0%
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