Updated on September 17, 2017
Ultimate Guide to Hair Regeneration 2017
Updated September 2017
This post contains a list of the most viable and relevant hair regeneration treatments that are in development and known of. Certain treatments have a greater potential than others to grow significant amounts of hair, and so they are listed in order of relevancy. Relevancy, in this case, is my opinion of the treatment’s combined efficacy and likelihood of becoming available the soonest. #1 is the most relevant and so on.
1. Shiseido/Replicel – Replicel’s hair growth treatment, RCH-01, involves culturing a person’s own hair follicle cells and then re-injecting them back into their scalp. First, a small punch-biopsy is removed from a person’s healthy hair follicles. Then, a specific cell is dissected from the follicle and cultured in a growth medium. The cells are replicated into the millions and then injected back into the person’s scalp. There is a short video about the procedure here. Replicel has been involved in a lot of activity over the past years to further develop their RCH-01 treatment into a worldwide success. For starters, Replicel created a partnership with Shiseido, which is the fourth largest cosmetic company in the world. In May 2014 Shiseido opened a huge biotechnology facility in Japan to accelerate the launch of Replicel’s hair technology RCH-01. This endeavor coincides perfectly with Japan’s new legislation which is designed to help expedite the trial process for stem cell technologies. In other words, Japan is an ideal place to launch a new cellular-based technology and get it to market quickly. To be clear, Shiseido and Replicel are separate companies. Replicel has licensed Shiseido the rights to bring RCH-01 to the world through an expedited regulatory path in Japan. It is worth mentioning that Shiseido also has its own scientists who are working on a separate hair regeneration technique using iPS cells. A treatment using iPS cells would be very advanced and could potentially produce an unlimited amount of hair regrowth.
Points of Interest: Shiseido is currently trialing Replicel’s RCH-01 in Japan for market approval by the end of 2018. Replicel is also planning on launching its own RCH-01 Phase 2 trial, hopefully sometime in 2017, for the regulatory approval pathway in North America.
Status: Shiseido’s Japan trial has launched in 3rd quarter 2016. Potential market release by 3rd quarter 2018 in Japan.
2. Fidia Pharma (Brotzu Lotion) – The “Brotzu Lotion” is a product that has been created through the work of Dr. Giovanni Brotzu, a vascular surgeon from Italy. This hair growth treatment was discovered while Dr. Brotzu was testing a drug formulation to treat vascular insufficiency in patients with diabetes. It was noticed that this treatment regrew hair on the patient’s legs which lead Brotzu’s team to test the formula on people’s scalps. Those tests proved worthwhile. The formula was then modified to use DGLA instead of PGE1, because DGLA would not be classified as a drug and would require much less clinical trials to be approved for hair growth. The known ingredients of this lotion include DGLA, Carnitine, S-equol, and Cationic Liposomes. The pharmaceutical company Fidia Pharma has acquired the rights to manufacture the Brotzu formula and is apparently performing a clinical study with the lotion for use in people with AGA. The study is still ongoing and Fidia has said the treatment should be available by the end of 2018.
Points of Interest: Fidia Pharma purchased the rights to develop this hair growth lotion after viewing its preliminary data. Dr. Brotzu has also released a compelling photo in 2016 of a young girl with alopecia areata who used the lotion and got impressive results. The treatment is extremely anticipated due to the fact it is classified as a cosmetic and could be acquired over the counter.
Status: Clinical efficacy trial is ongoing and Fidia Pharma has said the lotion should be released by the end of 2018.
3. Follica – Known for being one of the quietest companies on the horizon of hair growth treatments, Follica is also one of the most anticipated. Follica was founded in 2007 and its science is based on creating tiny wounds in the scalp to create hair follicle generation. Since the time of Follica’s original clinical trials which did not bring about the desired results, Follica has continued its research and development on combining novel compounds with micro-wounding for the proliferation of hair follicle formation. The name of Follica’s treatment has been revealed to be an acronym: “RAIN.” The RAIN treatment is a two part process which consists of 1) a micro wounding therapy combined with applied compounds which takes place in the clinic, 2) followed by a treatment package to be used at home consisting of a topical formula and an application device. The company has also developed a smart phone app to help users keep track of their at-home treatment routines.
Points of Interest: Follica’s co-founder Dr. George Cotsarelis is one of the household names in the hair follicle research world and has an array of hair growth related patents under his belt. About 10 years deep in development, Follica is planning to initiate a pivotal trial in early 2017, which, pending results, could lead to Follica’s hair growth therapy being approved for the market in 2018. In October 2016 Follica rolled out a new website to showcase the modalities of their treatment and smartphone app. The treatment, though not fully disclosed yet, stands to be a brief and tolerable procedure.
Status: Aiming at FDA clearance in 2018 for a potential commercial release in 2018/2019.
4. Samumed – SM04554 is a small-molecule topical solution that activates the Wnt pathway to grow hair. In March 2016 Samumed presented their highly anticipated phase 2 results at the American Academy of Dermatology. The Phase 2 results got a mixed response from the online world of hair growth enthusiasts, but the bottom line is that the treatment grew hair in the trial. Approximately, a 10% overall increase in hair density was observed in the best responding group who used SM04554. Before that study came to completion, Samumed initiated a second phase 2 study with a scalp biopsy analysis to better understand how their molecule gets the hair to grow. The initial phase 2 trial lead to the conclusion that this drug does not contain a “dose response” in patients who use it. This means that adding more of the drug to a patient’s anatomy does not lead to more results. Finding the “just right” dosage and application is important for this drug to work its best.
Points of Interest: Samumed began by breezing their way through clinical trials and completed an important phase 2 within about two years time from their initial startup. Now the company is looking into ways to optimize its drug to grow hair without a dose response and get to a Phase 3 trial.
Status: Have recently completed the biopsy analysis Phase 2 trial. Samumed has announced a third Phase 2 trial will happen sometime in 2017 before moving into a Phase 3 trial.
5. Allergan (from Kythera) – Setipiprant is an oral medication or pill. Specifically, it is a prostaglandin 2 receptor (PGD2R) antagonist. Setipiprant was originally developed for medical applications aside from hair growth and has undergone clinical trials for other indiciations. After George Cotsarelis at UPENN discovered that PGD2 receptors potentially play a major role in hair growth Kythera began pre-clinical trials with Cotsarelis’ office to determine if PGD2r antagonists were worth developing as a hair growth treatment. About two years later, Kythera announced it acquired the rights from Cotsarelis to use setipiprant for hair growth. Since that time Allergan has acquired Kythera and setipiprant with it. Setipiprant is now undergoing a phase 2A clinical trial in which finasteride is one of the control vehicles. The study is to be completed in September 2017.
Points of Interest: Setipiprant has already undergone a phase 3 trial in the US. This should save it some time in its FDA trial process. As a medication taken by mouth it is easy to administer and comply with.
Status: Undergoing Phase 2A clinial trial with a completion date of August 2018.
6. RiverTown Therapeutics Inc. – RT1640 is composed of minoxidil, cyclosporine-A, and a novel drug RT175. This compound has been developed by the founder of RiverTown Therapeutics Inc., David Weinstein MD, PhD. In a phase 1 trial, 100% of the people who used the treatment had satisfactory hair growth and, reportedly, several people had complete hair regeneration. RiverTown Therapeutics debuted their fantastic hair growth results on Follicle Thought. The three agents in RT1640 act on distinct pathways of AGA and synergize to promote the growth and maintenance of hair follicles. RT1640 also reanimates the melanocytic progenitor cells which give hair its color, hence, RT1640 is said to restore pigment to regenerated hair as well. Interestingly enough, RT1640 was brought to life through its founder’s personal interest in restoring his hair growth.
Points of Interest: These results for RT1640 are the most significant hair regeneration results I have ever witnessed from a topical treatment. Not only does RT1640 regrow hair, it also restores the pigment to the hair it regenerates. The strong safety profiles of the three agents that compose RT1640 should benefit the clinical trial process.
Status: Currently raising funds for a Phase 1B/2A study in 2017.
7. Follicum – Follicum is a Swedish biotechnology company that is developing human peptides for the use of stimulating hair growth and inhibiting hair growth. The lead candidate peptide of Follicum is called FOL-005. Specifically, it is called FOL-S-005 when being used to stimulate hair growth. Yes, interestingly enough, this same peptide is being trialed for uses in both hair growth and inhibition. According to the CEO of Follicum, Dr. Jan Alenfall, various factors will decide what growth/inhibition effect is attained from FOL-005; some of these factors include dosage, the way it is administered, and the type of hair follicle being treated. Apparently, Follicum will learn more about its peptide’s methods of action through its initial clinical trials. FOL-S-005 is aimed to be commercialized as a topical solution according to Follicum’s website. A phase 2A trial of FOL-005 will be completing in January 2017. Follicum has previously mentioned that they expect to observe hair inhibition from this safety trial, so we will have to wait and see what kind of data is acquired through this study.
Points of Interest: Follicum debuted a graph of FOL-S-005’s pre-clinical trial results on Follicle Thought, which were impressive. The hair growth effect of this peptide was discovered accidentally in mice in 2004. This means they’ve had 11 years to conduct R&D on this discovery. Follicum has been working with renowned hair researcher Ralf Paus since 2012 to further their R&D. They’ve initiated human trials which began in early 2016 and have secured two major manufacturing partners for their peptide technology.
Status: Phase 2B trial to be initiated in 2018.
8. Tsuji-Riken/Organ Technologies – Dr. Takashi Tsuji runs one of the most advanced stem cell labs in the world at the Riken Institute in Japan. Thankfully, he took up the task of using stem cells to grow hair in his R&D and subsequently got some major partners to help further his work. In mid-2016 it was announced that Riken would be establishing a joint venture with the electronics company Kyocera and the regenerative medicine company Organ Technologies to bring Dr. Tsuji’s hair regeneration treatment to the market. In the joint venture Kyocera will be developing the cell processing devices and RIKEN and Organ Technologies will be responsible for the stem cell culturing and manipulation, the production process, and implementation of the preclinical trials. The treatment involves extracting a small number of hair follicles from a person’s donor scalp area and then isolating two specific types of cells from the follicle – papilla cells and epidermal cells from the bulge region. These cells are then cultured, expanded, and combined to create a hair follicle “germ” or “follicular primordium.” Once the hair follicle germs are ready they are transported to a facility where they can be implanted back into a person’s scalp to grow hair.
Points of Interest: Tsuji has been doing hair follicle research for several years now and it’s awesome that the strategic partners are finally in place to bring his hair growth treatment to the world. Organ Technologies will develop this treatment in Japan which currently has the fastest track to market approval in the world for cellular therapies. Kyocera has announced that they aim for this treatment to be on the market in 2020.
Status: Currently undergoing research and development with a goal of market release in 2020.
9. Histogen – Histogen’s Hair Stimulating Complex (HSC) is a cell conditioned media that is derived from neonatal cells grown under embryonic-like conditions. It is an injectable serum that is used to stimulate the growth of new hair follicles as well as existing ones in a person’s scalp. This treatment was first announced around 2008 and a lot of people are eager for it to be released on the market. HSC has shown visual evidence of its efficacy and has had great numbers in clinical trials. The treatment has been trialed on both men and women and is said to be effective at regrowing hair at the temples as well as throughout the scalp. Compared to its initial inception, the current HSC product has been refined over the past few years to contain less cellular impurities and be a more concentrated formula of growth factors.
Points of Interest: This is a treatment that has a very high appeal due to its ease of application. Theoretically, you could walk in, receive injections, and walk out. No need to harvest your own cells and come back to get them re-injected such as with other cellular based treatments. The photo results are intriguing and apparently the actual treatment will include more individual injections across the scalp than what was administered in the the trial.
Status: Phase 3 trial for approval in Mexico awaiting to be initiated. Histogen is also presently looking to launch a trial for approval in China. Potentially on the market in Mexico after 2019.
10. Dr. Angela Chrisiano & Dr. Colin Jahoda (Aclaris & Rapunzel) – Two of the most prominent names when it comes to hair follicle research. Dr. Jahoda’s latest public work has been focused on 3D dermal papilla culturing, while Dr. Christiano has been popping up frequently in news headlines for her research on JAK inhibitors and hair growth. Dr. Christiano has even recently sold her JAK IP to Aclaris Therapeutics who is carrying out trials for JAK inhibtor’s use in treating AGA and alopecia areata. Even better, these two researchers are reportedly teaming up on Christiano’s new startup “Rapunzel” to develop a treatment using cultured hair follicle cells to regenerate hair. Christiano has recently stated “we can grow rat hair like it’s no tomorrow, but we think we can do it with human hair, too.”
Points of Interest: Dr. Jahoda implanted his own hair cells into his wife’s arm and found that his cells grew hair on her arm all the way back in 1999. In other words, the man is experienced in cellular hair growth research. Also, Jahoda and Christiano have both been issued a new patent related to 3D hair follicle culturing in January 2017.
Status: Undergoing preclinical work.