Pharmaceutical company Ferradrymix announced the success of its oral version of minoxidil in a Phase II/III clinical trial.
A Phase II/III clinical trial is defined as a "hybrid" study that combines two research protocols into one to accelerate drug development. It begins by assessing initial efficacy, safety, and optimal dosage on a moderate group of patients. Once positive results meet predefined criteria, the study is automatically expanded to include thousands of participants to confirm the results and compare the drug to standard treatments, reducing the time between phases and saving administrative and logistical costs.
On the morning of Monday, April 27, Ferradermix revealed the first results of a Phase II/III trial of its minoxidil formulation, codenamed VDPHL01, in which the drug passed all defined targets and significantly more participants who took it experienced hair growth compared to the placebo group.
The company now plans to obtain regulatory approval for the drug, which is likely to happen according to the data.
What is the difference between the new drug and topical minoxidil?
Topical minoxidil (applied to the scalp and available without a prescription under the name "Rogaine") has been used for more than three decades as a standard treatment for hair loss, especially pattern baldness, also known as male pattern baldness or androgenetic alopecia.
However, this traditional treatment has several drawbacks, most notably that it can cause redness and burning of the scalp, and it is toxic to cats and dogs, which requires extreme caution from pet owners in the method of application and storage. In addition, the sticky residue it leaves on the head is intolerable to some people.
In recent years, dermatologists have begun prescribing a very low-dose oral version of minoxidil to their patients instead of the topical version, even though the oral version is primarily given at higher doses to treat high blood pressure. However, this oral form is not officially approved for treating hair loss, meaning it is being prescribed off-label. While it has shown effectiveness in small studies, some researchers have expressed concerns about the quality of the data.
According to Ferradremix, VDPHL01 is not simply a generic version of regular oral minoxidil, but rather an exclusive extended-release formulation that provides consistent and sustained levels of the drug. These levels are designed to be high enough to ensure the drug's effects on hair growth, yet low enough to minimize potential cardiovascular side effects.
The new drug, VDPHL01, passed all the targets of the company's latest trial, "302," with over 86% of participants experiencing significant hair growth, compared to only 36% in the placebo group. Nearly two-thirds of participants who took two doses daily reported a noticeable improvement in hair density.
The six-month trial, involving over 500 men with mild to moderate hair loss, showed the drug to be safe and well-tolerated. The rate of side effects was similar to the placebo group, and no serious cardiac events were reported. Only about 5% experienced fluid retention in the extremities, and 1% discontinued treatment as a result.
If the drug receives regulatory approval, it will be the first new oral medication approved for pattern baldness in 30 years, and a competitor to finasteride (Propecia), which can cause side effects such as sexual dysfunction.
It is worth noting that other promising drugs for treating hair loss, such as clascoterone and PP405, have shown strong results in clinical trials and may reach the public within the next few years.
