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The Reality Behind Schedule I Therapeutic Development

 

Altasciences Tackles the Issues and Challenges Associated with Schedule I Therapeutic Development

Schedule I, or Class I (CI) drugs are currently restricted to research in the U.S., meaning that they are not approved for medical use, and are deemed at highest risk for abuse. Recent research on psychedelics and entactogens, of which are schedule I, is beginning to demonstrate potential therapeutic effects of these drugs for various medical indications. Approvals of such drugs for medical or therapeutic use will inevitably result in the rescheduling of these drugs from their current CI status. 

In this issue of The Altascientist, we uncover the following:

  • Regulatory environment and challenges — DEA 
  • Required preclinical and clinical studies specific to Schedule I or Class I (CI) drugs 
  • Manufacturing considerations

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For novel CNS-active Schedule I drugs, partner with Altasciences and benefit from our Schedule I licenses across every stage of early phase drug development. Our knowledge and operational expertise across preclinical, clinical, and manufacturing stages ensures complete continuity, data transfer, information sharing, and efficient timeline management... in real-time. 

Speak with an expert today for more information or to review your specific program requirements. 

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.​​​​