Updated on November 21, 2017
Rophe Pharma Announces Hair Growth Candidate
It was recently announced that Rophe Pharma will enter the hair growth market with a repurposed drug candidate. Robert Gadimian, CEO of Rophe Pharma, has put out a press release this month pertaining to the development of his hair growth compound RPHE-7193. See below for text of press release.
“Rophe Pharma, announces it has applied for the International Patent Application (PCT application) for RPHE-7193, which is a topical drug for the treatment of hair loss. Hydralazine, the active substance in RPHE-7193, was approved decades ago for treatment of blood pressure but in an exciting development it spurred hair growth as a side effect.
NEW PRODUCT HAS FDA APPROVED COMPOUND
Rophe Pharma plans to apply for the expedited review of its patent with the US Patent and Trademark Office before the end of 2017. In an exploratory study conducted with RPHE-7193 significant hair growth is observed in men after 8 weeks of use compared other hair loss products that take 6-12 months to show noticeable hair growth.
The background for hydralazine in RPHE-7193 is almost the same as minoxidil, the active substance in Rogaine. Hydralazine is currently approved as a blood pressure drug. RPHE-7193 does not contain alcohol and polyethylene glycol, the two solvents in other hair products that cause skin irritation and sensitivity, hence RPHE-7193 is formulated to avoid these skin related side effects.
RPHE-7193 WILL BE STUDIED IN RELEVANT AGE GROUPS
Robert Gadimian explains the two already approved drugs for male pattern baldness (MPB), have not been studied in men above age 41 but Gadimian is testing RPHE-7193 in that age group — since as mentioned above, most of the men who suffer from hair loss are above age 41.
Gadimian also explains that the only 2 available treatment for hair loss (minoxidil and finasteride ) don’t have satisfactory hair growth properties, leaving men who suffer from hair loss desperate. Table 1 presents the clinical study results for Rogaine max strength solution and as shown, At week, 16, there is no difference between placebo and minoxidil! Even after 32 weeks of treatment, half of the patients only see minimal growth.
|Table 1: Investigator evaluation of Hair Growth using Rogaine Max strength (5%) solution|
|5% Rogaine||2% Rogaine||Placebo|
* As bad as placebo
** Little better than placebo
Hydralazine has demonstrated much greater efficacy regarding hair growth stimulation in humans than Rogaine and should prove to be very attractive to men and women who are unhappy with the inconsistent results often yielded by Rogaine. Table 2 presents the difference between minoxidil and RPHE-7193.
|Table 2: Comparison of minoxidil and RPHE-7193|
|Rogaine has alcohol and PEG which are known skin irritants||RPHE-7193 does not contain alcohol and PEG|
|There are no clinical data with men over age 41.||RPHE-7193 will be studies in men up to age 65|
|It may take up to 4 months or longer to notice new hair growth||Improvements have been observed in 90% of men after 6-8 weeks of treatment with RPHE-7193|
Robert Gadimian is working on raising the funds required to initiate the clinical studies in US and pursue the development of this drug in order to being in to the market and provide a needed alternative for men and women who suffer from hair loss.”
Some key points I’ve noticed while reading up on RPHE-1793 :
- The compound will go through FDA trial process
- Can start at Phase 2 for hair growth due to previous approval for other indication
- Will be trialed against minoxidil in its clinical trial
Please check the press releases below to gain more details: