Tasimelteon is a synthetic melatonin receptor agonist used as an active pharmaceutical ingredient in pharmaceutical formulations for the management of Non-24-Hour Sleep-Wake Disorder (Non-24). It selectively activates the MT1 and MT2 melatonin receptors and supports regulation of the circadian sleep-wake cycle. PubChem identifies tasimelteon as a melatonin receptor agonist and lists its molecular formula as C15H19NO2 with a molecular weight of 245.32 g/mol.
Tasimelteon is a small-molecule pharmaceutical API belonging to the benzofuran and cyclopropane chemical classes. It is the active pharmaceutical ingredient used in oral formulations developed for circadian rhythm sleep-wake disorders.
The API is associated with the CAS number 609799-22-6 and has the molecular formula C15H19NO2. Its IUPAC name is N-[[(1R,2R)-2-(2,3-dihydro-1-benzofuran-4-yl)cyclopropyl]methyl]propanamide.
| Parameter | Details |
|---|---|
| Product Name | Tasimelteon |
| API Type | Small-Molecule API |
| CAS Number | 609799-22-6 |
| Molecular Formula | C15H19NO2 |
| Molecular Weight | 245.32 g/mol |
| Therapeutic Class | Melatonin Receptor Agonist |
| Pharmacological Target | MT1 and MT2 Melatonin Receptors |
| Primary Application | Non-24-Hour Sleep-Wake Disorder |
| Stereochemistry | (1R,2R) |
| IUPAC Name | N-[[(1R,2R)-2-(2,3-dihydro-1-benzofuran-4-yl)cyclopropyl]methyl]propanamide |
| Appearance | White to off-white crystalline solid/powder* |
*Final appearance should be confirmed against the applicable batch specification/CoA.
Tasimelteon API is primarily used in the development and manufacture of pharmaceutical products intended for the treatment of Non-24-Hour Sleep-Wake Disorder. It acts as an agonist at melatonin MT1 and MT2 receptors, helping regulate circadian rhythm.
Tasimelteon is also an important API for pharmaceutical research involving melatonin receptor agonists, circadian rhythm regulation and sleep-wake disorders.
Tasimelteon active pharmaceutical ingredient can be evaluated using a comprehensive analytical control strategy covering identity, assay, purity, stereochemical purity and physical properties. The EMA assessment report for Hetlioz describes active-substance testing including IR identity, chiral HPLC, loss on drying, water content, HPLC assay/purity, related substances, residual solvents, polymorphic form, particle size and microbial limits.
Typical quality-control testing may therefore include:
Swapnroop provides pharmaceutical API solutions with an emphasis on quality systems, analytical testing, documentation and supply requirements for pharmaceutical development and manufacturing. Tasimelteon API can be supported with appropriate quality documentation and analytical information according to the applicable product specification.
Tasimelteon should be packaged in suitable, well-closed pharmaceutical containers that protect the material from moisture, light and environmental contamination. Storage conditions should follow the approved product specification and stability data.
The EMA assessment report notes packaging designed to protect the active substance from moisture and light.
Depending on customer and regulatory requirements, documentation may include:
Swapnroop focuses on supplying pharmaceutical APIs with controlled quality, analytical support and documentation for pharmaceutical development and manufacturing requirements. Tasimelteon API can be offered with appropriate specifications and quality documentation based on the intended application and applicable regulatory requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |