Advances in Clinical Research on CYP2D6 inhibitor

The CYP2D6 gene encodes the CYP2D6 enzyme, which is a crucial member of the cytochrome P450 system, a crucial enzyme in the metabolism of various drugs. The CYP2D6 enzyme in humans is mainly expressed in the liver, but is also present in the central nervous system, followed by the myocardium and small intestine. Although it represents only 2% content in the liver, it participates in the metabolism of as many as 25% of commonly used clinical drugs, including antidepressants, antipsychotics, antihypertensives, antiarrhythmics, tamoxifen, and others.

Among all the cytochrome P450 enzymes involved in drug metabolism, the enzyme CYP2D6 is the only non-inducible enzyme, leading to a significant influence of genetic variations on individual differences in enzyme activity.

The CYP2D6 gene exhibits high polymorphism, with over 100 known alleles. The alleles of CYP2D6 have been extensively researched in a variety of areas such as geography, race, and ethnicity, and there are significant differences. Most known alleles are sorted into several functional groups: normal function (CYP2D6*1 and *2), reduced function (CYP2D6*9,*10, and *41), and no function (CYP2D6*3-*6).

CYP2D6 Competitive Landscape

According to the data provided by Patsnap Synapse-Global Drug Intelligence Database: the following figure shows that as of 24 Sep 2023, there are a total of 7 CYP2D6 drugs worldwide, from 14 organizations, covering 18 indications, and conducting 368 clinical trials.

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Based on the analysis of the provided data, the current competitive landscape of target CYP2D6 in the pharmaceutical industry is characterized by the presence of multiple companies at different stages of development. Axsome Therapeutics, Inc. and GSK Plc are leading in terms of the highest stage of development. The approved drugs under this target are indicated for various conditions, including Depressive Disorder, Major, Seasonal Affective Disorder, and Alzheimer Disease. Small molecule drugs are progressing rapidly, indicating intense competition in this area. The United States and China are the countries that have shown significant progress in the development of drugs targeting CYP2D6. Overall, the future development of target CYP2D6 holds promise, with ongoing research and development efforts by various companies and countries.

The globally approved CYP2D6 inhibitor on the market: Bupropion Hydrochloride/Dextromethorphan

Bupropion Hydrochloride/Dextromethorphan is a small molecule drug that targets multiple receptors and enzymes in the body, including CYP2D6, DAT, NMDA receptor, adrenergic receptor, and σ1 receptor. It falls under the therapeutic areas of Other Diseases and Nervous System Diseases, indicating its potential use in treating a range of conditions beyond the traditional scope of medicine.

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The drug has been approved for various indications, including Depressive Disorder, Major, Dementia due to Parkinson's disease, Alzheimer Disease, Agitation, Depressive Disorder, Treatment-Resistant, Psychomotor Agitation, Smoking Cessation, and Opioid-Related Disorders. This suggests its versatility in addressing different mental health disorders and substance abuse issues.

Bupropion Hydrochloride/Dextromethorphan was developed by Antecip Bioventures, an originator organization in the pharmaceutical industry. It received its first approval in the United States in August 2022, making it a relatively recent addition to the market. The drug went through a priority review and was classified as a breakthrough therapy, indicating its potential to provide significant benefits over existing treatment options.

As a small molecule drug, Bupropion Hydrochloride/Dextromethorphan is likely to have a well-defined chemical structure, allowing for easier synthesis and formulation. This can contribute to its commercial viability and potential for widespread use.

In summary, Bupropion Hydrochloride/Dextromethorphan is a small molecule drug developed by Antecip Bioventures. It targets multiple receptors and enzymes in the body and has been approved for various indications, including depressive disorders, dementia, agitation, and substance abuse disorders. Its first approval was obtained in the United States in August 2022, following a priority review and breakthrough therapy designation. The drug's versatility and recent approval make it a promising addition to the pharmaceutical market, particularly in the field of biomedicine.