Khaberni - The pharmaceutical company "Veradermix" announced the success of its oral version of the drug minoxidil in a phase II/III clinical trial.
The phase II/III clinical trial is known as a "hybrid" study that merges two research protocols into one pathway to accelerate the drug development process, starting with evaluating preliminary efficacy, safety, and the optimal dosage on a medium-sized patient group. Once positive results meeting predefined criteria emerge, the study automatically progresses to expand its scale to include thousands of participants to confirm the findings and compare the drug with standard treatments, thereby reducing the time between phases and saving administrative and logistical costs.
On the morning of Monday, April 27, "Veradermix" unveiled the initial results of its phase II/III trial for its formulation of minoxidil, codenamed VDPHL01, which passed all designated targets and saw a significantly larger number of participants experiencing hair growth compared to the group that received a placebo.
The company is now planning to obtain regulatory approval for the drug, which is likely to occur according to the data.
What is the difference between the new drug and topical minoxidil?
Topical minoxidil (applied to the scalp and available over-the-counter under the name "Rogaine" for more than three decades) has been a standard treatment for hair loss, particularly male pattern baldness, also known as androgenetic alopecia or hereditary baldness.
However, this traditional treatment has several drawbacks, including the potential to cause redness and burning on the scalp, as well as being toxic to cats and dogs, which requires owners to be extremely cautious in how they apply and store it. Additionally, some people cannot tolerate the sticky residue it leaves on the head.
In recent years, dermatologists have been prescribing a low-dose oral version of minoxidil to their patients instead of the topical version, although the oral form is primarily given in higher doses to treat high blood pressure. However, this oral version is not officially approved for treating hair loss, meaning it is prescribed off-label. Despite its effectiveness in small studies, some researchers have expressed concerns about the quality of this data.
What distinguishes the drug VDPHL01?
According to "Veradermix," VDPHL01 is not just a replicated version of ordinary oral minoxidil, but a unique extended-release formulation that provides stable and sustained drug levels. These levels are designed to be high enough to ensure the drug's effects on hair growth, yet low enough at the same time to minimize potential cardiovascular side effects.
The new drug, VDPHL01, surpassed all objectives of the company's latest "302" trial, where more than 86% of participants experienced significant hair growth, compared to only 36% in the placebo group. About two-thirds of participants taking two daily doses reported noticeable improvements in hair density.
The trial, which lasted 6 months and included more than 500 men suffering from moderate to mild hair loss, showed that the drug is safe and well-tolerated. The rate of side effects was similar to the placebo group, with no severe heart-related events recorded. Approximately 5% only experienced fluid retention in the limbs, and 1% discontinued the treatment because of it.
If the drug receives regulatory approval, it will be the first new oral medication approved for male pattern baldness in 30 years, competing with finasteride (Propecia), which can cause side effects like sexual dysfunction.
It is worth noting that other promising hair loss treatments, such as Clascoterone and PP405, have shown strong results in clinical trials and may reach the public in the next few years.
