Drug Insights

An In-depth Analysis of Betahistine Hydrochloride's R&D Progress

18 September 2023
4 min read

Betahistine Hydrochloride's R&D Progress

Betahistine Hydrochloride is a small molecule drug that targets both the H1 receptor and H3 receptor. It is primarily used in the treatment of various otorhinolaryngologic diseases, nervous system diseases, and cardiovascular diseases. The drug has been approved for use in the treatment of arteriosclerosis, cerebrovascular disorders, tinnitus, vertigo, Meniere disease, and vestibular diseases.

The highest phase of development for Betahistine Hydrochloride is approved globally. The drug received its first approval in the United States in January 1966, making it a well-established medication with a long history of use.

Betahistine Hydrochloride is regulated as an orphan drug. Orphan drugs are medications that are developed to treat rare diseases or conditions that affect a small number of patients. These drugs often receive special regulatory status and incentives to encourage their development and availability.

👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug.

Mechanism of Action for Betahistine Hydrochloride: H1 receptor antagonists & H3 receptor antagonists

H1 receptor antagonists and H3 receptor antagonists are terms related to biomedicine.

From a biomedical perspective, H1 receptor antagonists are drugs that block the action of histamine at the H1 receptor. Histamine is a chemical released by the immune system during an allergic reaction, and it binds to H1 receptors, causing symptoms like itching, sneezing, and watery eyes. H1 receptor antagonists, also known as antihistamines, work by preventing histamine from binding to H1 receptors, thereby reducing or preventing these allergic symptoms.

On the other hand, H3 receptor antagonists are drugs that block the action of histamine at the H3 receptor. The H3 receptor is primarily found in the central nervous system and plays a role in regulating the release of neurotransmitters like histamine, dopamine, and serotonin. By blocking the H3 receptor, H3 receptor antagonists can modulate the release of these neurotransmitters, potentially affecting various physiological processes such as sleep, cognition, and appetite.

In summary, H1 receptor antagonists and H3 receptor antagonists are drugs that respectively block the action of histamine at the H1 and H3 receptors. They are used to treat different conditions related to allergies and central nervous system regulation.

Drug Target R&D Trends for Betahistine Hydrochloride

According to Patsnap Synapse, as of 10 Sep 2023, there are a total of 4 H1 receptor + H3 receptor drugs worldwide, from 8 organizations, covering 12 indications, and conducting 87 clinical trials.

The analysis of the target H1 receptor + H3 receptor reveals a competitive landscape with companies at different stages of development. Hubei Jiu'an Pharmaceutical Group Co., Ltd. has achieved the highest development phase with an approved drug. Indications such as Vertigo, Meniere Disease, Tinnitus, Cerebrovascular Disorders, and Arteriosclerosis have seen approvals, indicating the therapeutic potential of targeting the H1 receptor + H3 receptor. Small molecule drugs dominate the development pipeline, with one approved and four inactive. The European Union, United States, and China are leading in terms of development phases, with China showing significant progress. Further analysis and research are required to understand the R&D progress of companies, the potential of targeting inactive indications, the competitive landscape around biosimilars, and the specific developments in China.

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Conclusion

In summary, Betahistine Hydrochloride is a small molecule drug that targets the H1 and H3 receptors. It is used in the treatment of various otorhinolaryngologic diseases, nervous system diseases, and cardiovascular diseases. The drug has been approved globally, with its first approval dating back to 1966 in the United States. It is regulated as an orphan drug, indicating its use in treating rare diseases or conditions.

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