Why is RU58841 not on the market?  If RU58841 is so great then why isn’t it more popular and approved by FDA

RU58841 is a non-steroidal anti-androgen drug originally use to treat hair loss and acne, which achieve remarkable results in clinical studies, but not carry out phase 3 clinical trials, resulting in later unable to promote and enter the market. All you can buy now are chemical materials use in research, not finished drugs.

What is the reason for the delay in the launch of RU58841? Is it really because of any serious side effects?

RU58841 is not a new product that has been studied in recent years, but has appeared in the 1980s, and has been decades of history. It was first discovered by French researchers at Roussel Uclaf, a pharmaceutical company. It was a topical non-steroidal anti-androgen drug with potential applications for the treatment of androgenic alopecia (male and female pattern baldness) and acne. But in the 1990s and early 2000s the company went through corporate changes, acquisitions that led to the eventual acquisition of the company’s pharmaceutical division. This also affects the development continuity and priority of the RU58841 project.

The development could not be sustained, resulting in very limited clinical trial data and unable to obtain regulatory approval for marketing. All regulatory approvals by the FDA or EMA are based on extensive, large-scale trials to verify their safety and efficacy.

Of course, the reason why it can not successfully listed may also have commercial interests, in the United States market hair loss products are basically occupied by finasteride and minoxidil, the new RU58841 may occupy the original profit space, so this has become a factor hindering its listing.

As a drug that has appeared for decades, and has undergone changes in corporate ownership, its patent ownership is not clear, and there are adverse risks that will affect the company’s judgment on this project.

Therefore, under the combined influence of various factors, RU58841 seems to have become an abandoned project. Although it is more considered from the perspective of commercial profit, no one can say that it is safe enough due to the lack of sufficient clinical research data. Any attempt to study a compound is risky, and it is best to start your attempt after fully understanding it.