Deuterated Drugs - The Journey From Lab to Market
The pharmaceutical industry is constantly seeking innovative approaches to improve drug efficacy, safety, and stability. One of the more intriguing advancements in recent years is the development of deuterated drugs. Deuterated compounds present a compelling option for optimizing existing drugs and developing new therapies across various disease areas. The potential to extend patent life and reduce development costs makes deuterated drugs attractive for pharmaceutical companies looking to innovate while managing risk.
Deuterated Drugs: Deuterium is substituted for hydrogen in drug molecules, this seemingly small change can lead to significant differences in the way the body metabolizes the drug. The carbon-deuterium bond is stronger than the carbon-hydrogen bond, making the drug more resistant to enzymatic breakdown in the liver.
The following are general protocols involved in the Deuteration of drugs:
- The science behind replacing hydrogen with deuterium
- Discovery and Preclinical Research
- Clinical Trials
- Regulatory Approval
- Market Adoption and Commercial Success
The success of the first deuterated drugs, such as deutetrabenazine, has opened the door to further exploration in this area. Companies are now investigating the potential for deuteration in various therapeutic areas, including oncology, neurology, and infectious diseases.
DeuTetrabenazine:
Drug : Deutetrabenazine (Austedo)
Parent Drug : Tetrabenazine
Therapeutic indication : Drug-induced dyskinesia
FDA Approval : April 2017
Originator : Auspex Pharmaceuticals
Development : Teva Pharmaceutical
Orphan Drug Designation : Yes
ODD Exclusivity : 7 years
NCE Exclusivity : 5 years
Approval : Hybrid 505(B)(2)
Deutetrabenazine is a deuterated form of tetrabenazine, designed to treat hyperkinetic movement disorders such as Huntington's disease and tardive dyskinesia.
Clearsynth Deuterated drug Indian patent granted:
- Drug-induced hepatic injuries (with Nefazodone) is associated with a risk of elevated need for a liver transplant, or even death.
- As per literature reactive metabolite 3 may contribute to the aetiology of nefazodone hepatotoxicity by forming covalent adducts to hepatic proteins, with potentially deleterious consequences.
- Deuteration at the soft spot is expected to significant decrease in the concentration level of reactive metabolite 3 and may increase the safety profile of the drug molecule