Where Is The Proposed Replicel Shiseido Hair Loss Treatment?
Of all the proposed hair loss solutions currently being developed, the one that was estimated to have the earliest release date was one from Replicel in partnership with Japanese beauty brand, Shiseido.
The injectable treatment for male and female pattern baldness was estimated in July 2015 to be introduced in 2018. So, given it is now August 2018, many of you have been asking us something we'd like to know too - where is it..?
According to Replicel, the product known as RCH-01 is still scheduled for release in the third quarter of 2018 - meaning any time between October and December. In answer to a 23rd July 2018 Twitter query regarding when this would be released, a Replicel representative responded: "It's all up to Shiseido in Asia".
This suggests it may be that Shiseido has other ideas about this product pipeline as, whilst no information is forthcoming from the company, its March 2018 business forecasting information covering the 2018-2020 period suggests novel hair growth innovations will play a part in its new product releases some time in the next two years. No more specific details are provided, including any potential pricing estimates.
Replicel states in its January 2018 shareholder update that these investors can expect to see within the year, "Data from the clinical research being funded by Shiseido in Japan measuring the benefit of RCH-01 injections in men and women suffering from hair loss due to androgenic alopecia." The results from its initial clinical trials into this injectable Male Pattern Baldness treatment were previously released in March 2017.
What this could mean is that Replicel has completed the necessary trials and the drug itself is ready to be put forward for the crucial medical regulatory board certifications in the relevant countries, but Shiseido is holding off introducing the product to market. The reason products - including medications such as hair loss treatments - are not always released as soon as they are finalised can often come down to business strategy, logistics and marketing requirements.
It can also be due to delays in obtaining the necessary sign-offs required from medical regulatory boards, such as the licensing from the UK's MHRA and approval from the FDA in America. If the product is originating in Japan, a local sign off from the PMDA (the Pharmaceuticals and Medical Devices Agency) may be necessary before these other international confirmations are sought. As yet, no such assurances have been listed on the websites for any of these bodies.
Whilst we cannot comment on the efficacy of the RCH-01 product in relation to regrowing hair given we have not tried it and the details of the latest clinical trial results have not yet been released, what we can say is that if you are a man or a woman concerned about thinning hair or a receding hairline, it is best to seek assistance as soon as possible. The reason for this is that both Male and Female Pattern Baldness are permanent, progressive forms of hair loss - they will not clear up of their own accord and will gradually worsen over time.
There are already clinically-proven topical and oral treatments available - with both MHRA licenses and FDA approvals - for both these common conditions. Whilst men aged 18 and over can use both, men and women from 16 years of age can use the topical treatment only. These can be bolstered by accompanying products to support healthy hair growth, which can range from home-use low level laser therapy devices, to highly-targeted food supplements, such as Hair Vitalics.
As long as the hair follicles remain responsive and capable of normal hair growth, this route can be worthwhile exploring. In cases where the shedding has become too severe and baldness has developed, surgical intervention in the form of a hair transplant - as long as there is sufficient good quality donor hair around the back and/or sides of the scalp - may be the only hair restoration option left open.
It looks as if 2020 may be a remarkable year for hair loss breakthroughs as, not only is it likely we will see this Shiseido/Replicel product released then, but the first JAK inibitor hairloss treatments are also estimated to have a release date of 2020-2021. Whilst other potential treatments being developed - including Shiseido/Replicel - have had wavering timelines throughout their progression, the JAK inhibitor treatments, particularly those coming via the partnership of the medical school at New York's Columbia University and Aclaris Therapeutics, have regularly released updates at each stage of the development process, all seemingly showing them to be on course for the predicted release date. Again, whether it remains on course depends on the last stages of the clinical trial process currently underway all going to plan, then obtaining the necessary regulatory certification in a timely manner.
Should future treatments come along that out-perform established, existing methods not just in terms of efficacy but also in safety and tolerability, then it should be easy for people to switch from the old (current) form to the new treatment if they want to. However, given hereditary hair loss in men and women will cause thinning hair to continually deteriorate, it can be wise to start treating it as early as possible with existing methods in order to get a head start in the meantime.
The injectable treatment for male and female pattern baldness was estimated in July 2015 to be introduced in 2018. So, given it is now August 2018, many of you have been asking us something we'd like to know too - where is it..?
Potential delay
According to Replicel, the product known as RCH-01 is still scheduled for release in the third quarter of 2018 - meaning any time between October and December. In answer to a 23rd July 2018 Twitter query regarding when this would be released, a Replicel representative responded: "It's all up to Shiseido in Asia".
This suggests it may be that Shiseido has other ideas about this product pipeline as, whilst no information is forthcoming from the company, its March 2018 business forecasting information covering the 2018-2020 period suggests novel hair growth innovations will play a part in its new product releases some time in the next two years. No more specific details are provided, including any potential pricing estimates.
Replicel states in its January 2018 shareholder update that these investors can expect to see within the year, "Data from the clinical research being funded by Shiseido in Japan measuring the benefit of RCH-01 injections in men and women suffering from hair loss due to androgenic alopecia." The results from its initial clinical trials into this injectable Male Pattern Baldness treatment were previously released in March 2017.
What this could mean is that Replicel has completed the necessary trials and the drug itself is ready to be put forward for the crucial medical regulatory board certifications in the relevant countries, but Shiseido is holding off introducing the product to market. The reason products - including medications such as hair loss treatments - are not always released as soon as they are finalised can often come down to business strategy, logistics and marketing requirements.
It can also be due to delays in obtaining the necessary sign-offs required from medical regulatory boards, such as the licensing from the UK's MHRA and approval from the FDA in America. If the product is originating in Japan, a local sign off from the PMDA (the Pharmaceuticals and Medical Devices Agency) may be necessary before these other international confirmations are sought. As yet, no such assurances have been listed on the websites for any of these bodies.
Worth the wait?
Whilst we cannot comment on the efficacy of the RCH-01 product in relation to regrowing hair given we have not tried it and the details of the latest clinical trial results have not yet been released, what we can say is that if you are a man or a woman concerned about thinning hair or a receding hairline, it is best to seek assistance as soon as possible. The reason for this is that both Male and Female Pattern Baldness are permanent, progressive forms of hair loss - they will not clear up of their own accord and will gradually worsen over time.
There are already clinically-proven topical and oral treatments available - with both MHRA licenses and FDA approvals - for both these common conditions. Whilst men aged 18 and over can use both, men and women from 16 years of age can use the topical treatment only. These can be bolstered by accompanying products to support healthy hair growth, which can range from home-use low level laser therapy devices, to highly-targeted food supplements, such as Hair Vitalics.
As long as the hair follicles remain responsive and capable of normal hair growth, this route can be worthwhile exploring. In cases where the shedding has become too severe and baldness has developed, surgical intervention in the form of a hair transplant - as long as there is sufficient good quality donor hair around the back and/or sides of the scalp - may be the only hair restoration option left open.
It looks as if 2020 may be a remarkable year for hair loss breakthroughs as, not only is it likely we will see this Shiseido/Replicel product released then, but the first JAK inibitor hairloss treatments are also estimated to have a release date of 2020-2021. Whilst other potential treatments being developed - including Shiseido/Replicel - have had wavering timelines throughout their progression, the JAK inhibitor treatments, particularly those coming via the partnership of the medical school at New York's Columbia University and Aclaris Therapeutics, have regularly released updates at each stage of the development process, all seemingly showing them to be on course for the predicted release date. Again, whether it remains on course depends on the last stages of the clinical trial process currently underway all going to plan, then obtaining the necessary regulatory certification in a timely manner.
Should future treatments come along that out-perform established, existing methods not just in terms of efficacy but also in safety and tolerability, then it should be easy for people to switch from the old (current) form to the new treatment if they want to. However, given hereditary hair loss in men and women will cause thinning hair to continually deteriorate, it can be wise to start treating it as early as possible with existing methods in order to get a head start in the meantime.
The Belgravia Centre
The Belgravia Centre is a world-renowned group of a hair loss clinic in Central London, UK. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation from anywhere in the world for home-use treatment.
View our Hair Loss Success Stories, which includes the world's largest gallery of hair growth photos and demonstrates the level of success that so many of Belgravia's patients achieve.
