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 | |
| Week 16 | |||
| No growth | 44%* | 53% | 42% |
| Minimal growth | 49% | 46% | 46% |
| Moderate growth | 4% | 1% | 13% |
| Dense growth | 3% | 0% | 0% |
| Week 32 | |||
| No growth | 14% | 14% | 9% |
| Minimal growth | 46%** | 51% | 34% |
| Moderate growth | 38% | 35% | 57% |
| Dense growth | 2% | 0 | 0 |
* 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 | |
| Minoxidil | 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:
http://robertgadimian.com
Posted in Hair Growth Treatment
An important component that is missing from all these hair growth products is that they do not stop the underlying cause of hair loss and therefore even if more effective than rogaine will only serve to delay the inevitable.
We havent spoken for a while, but we have updated our Stop and Regrow website.
I would be very interested in your thoughts as to whether you find it more compelling than the previous one. And if not, what are we missing?
Majority of the drugs treat symptoms and not the root cause, Examples are hypertension, diabetes, painkiller, etc., etc. They only treat the symptoms and not the root cause. It is extremely hard to fight the natural biology of the body with drugs.
I would like to be part of a clinical trial. PLEASE.
Kate, if you were intending to get in touch with Tracey please email her directly tracey@stopandregrow.com (marketing is not allowed via comments)
Thanks!
Thanks so much for all your work at bringing all the newest info to us. I so appreciate you.
Between your twitter feed and this blog you are coming at us with both barrels loaded. Some good news lately. It will be interesting to see if this stuff is available with prescription, we all know someone will get there hands on it. Thanks again. Keep it coming
My brother Chris ☝
Hi,
I am looking for investors who are willing to invest in this drug. I have a couple of investors who are interested but so far, nobody has their hand on it yet.
Have you thought about crowdfunding?
How much do you need?
I need around 1.5 million dollars. The issue with crowd funding is that there will be too many investors and hard to manage.
Yes, cheers for the info and for all the work you’re doing. I have no real faith in these topical compounds for growing hair back though, especially the all important frontal region and hairline (I tried finasteride 20 years ago and it made no difference so I have some experience there). To me, stem cell/hair replication techniques definitely seem like the best way forward. Also, have you investigated any of the hair transplant clinics in Turkey? The cost is very minimal compared to transplants elsewhere (only $1500-$3000 US including accommodation) and the results are usually pretty amazing. If you have minimal to medium amounts of hair loss then a transplant in Turkey seems like a very viable option. Here’s a case I looked at today on “Realself” (link below). “Realself” is a great site with plenty of reviews, before-and-after photos, and patient testimonies regarding the various clinics in Turkey (a real Mecca for hair transplantation for some reason). Definitely worth checking out if you get the urge. https://www.realself.com/review/istanbul-turkey-fue-hair-transplant-maralklinik-4900-grafts?rsuid=3667171&utm_source=Sailthru&utm_medium=email&utm_campaign=NL1XDayPM%202017-09-20&utm_term=GlobalNLSuperStar#
Admi, do you know if this drug can cause the same side effects like minoxidil does( headache, heart beating, pain in the eyes,shedding, etc)
Thank you for the update.
Hi,
The only side effect I have seen are itching and skin redness that occurs in 20% of the people. Minoxidil is very powerful anti-hypertensive drug that has systemic effect but hydralazine is not as potent anti-hypertensive drug as minoxidil and should not have any systemic side effect.
That’s very interesting Robert, I was not aware previously.
Robert, I’ve been fight hair loss since I was 18, now 54. I used Minoxidil off label before Upjohn released (and FDA approved) 2% as a topical hair loss RX drug. I saw a forward thinking derm in San Francisco who had it compounded in the pharmacy in his building. Then he did the same with 5% before that was approved/released. Different animal but also finasteride. All these drugs including Hydralazine have something in common, they were already approved for other diagnosis and he prescribed for off label use. Not a long term strategy, just food for thought.
You will never find a drug that works for everybody. Therefore, there are always several drugs for the same condition since people respond differently. So hydralazine, minoxidil, finasteride will provide options. The other hair growth drugs that are under development will not work for everybody either. So the more options there are, the better for people who suffer from hair loss.
I think we will see amazing results for baldness treatment in late 2018 including Shiseido and this advertised product
So when can we expect this product to be on the shelves??
There is no answer to that at this time.
I have run Phase 2 and phase 3 clinical studies, and submit NDA and go through the approval process so we are talking about years until it hits the market.
“Can start at Phase 2 for hair growth due to previous approval for other indication”
Doesn’t Japan only require up to phase 2 trial?
Yes, since the drug is already approved, I can jump to P2 directly but still need clinical studies.
https://www.omicsonline.org/open-access/a-new-topical-formulation-of-minoxidil-and-finasteride-improves-hair-growth-in-men-with-androgenetic-alopecia-2155-9554.1000253.php?aid=3889
there are these products available in India, Morr F, a combination of 5% minoxidil and 0.1% finasteride .
Has topical finasteride shown to help hair growth? Only the oral form has clinical data.
Admin /
a new groundbreaking study came out of UCLA that found that increasing lactate production in mice via the use of two different topical drugs led to increased hair growth both times (through hair stem cell activation.
Please bring this subject through the new properties RCGD423 and UK5099 /
● Are there alternatives currently pending completion of the study?
I don’t believe those drugs are approved for market use, so I will keep an eye on this.
what about Brotzu? it’s gonna arrive in 2018?
Thanks!
That’s what they say
Not interested personally…May be of interest to others
hey adminn ! when will came new news ??
Should have some news this coming week.
I hope its good news, thats what we are waiting for.
I’m certainly waiting for good news too, Pjotr. We all do the best we can, any news is good news. It’s a process.
Nice thought, as in this modern world – hair transplantation will be the most required one.
According to the America Hair Loss Association, MPB ― also referred to as androgenetic alopecia ― accounts for more than 95% of hair loss in men. By the age of 35, two-thirds of American men will experience some degree of appreciable hair loss; by the age of fifty, approximately 85% of men will contend with significantly thinning hair. Approximately, 25% of men who suffer from MPB began the painful process of losing their hair before reaching the age of 21. For men unhappy with MPB, the effects can be wide-ranging and affect quality of life, both personal and professional. In spite of this widespread issue, no drug has been able to satisfactorily solve MPB in all men.