Updated October 2018
This post contains a list of the hair dryer recall 2018 most viable and relevant hair regeneration treatments which are in development and known of. They can be referred to as hair loss cures, hair growth treatments, hair loss treatments, or cures for alopecia. The treatments listed in this guide are given an estimated rating based on their potential of hair growth efficacy and how soon the treatment can be released to the public market. #1 is the most relevant and so on. Ratings on the list are always subject to change depending on information that becomes available.
1. – 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. 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 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 who are working on a separate hair regeneration technique using iPS cells. A treatment using iPS cells would be a further advancement and could potentially produce an unlimited amount of hair regrowth.
Points of Interest: Shiseido is 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, estimated to take place in 2019-beyond, for the regulatory pathway in North America. Lee Buckler of Repicel has told Follicle Thought that an announcement coming from Shiseido in Sept/Oct 2018.
Status: Shiseido’s Japan trial launched in 3rd quarter 2016. Depending on the date of the trial’s completion, which has not been disclosed, the treatment could become available in mid 2019.
2. – Trinov aka the “Brotzu Lotion” is a formula created by 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 the drug formula regrew hair on the patients’ legs during the vascular study 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 Italy based pharmaceutical company Fidia Pharma has acquired the rights to manufacture the Brotzu formula for hair and is apparently performing a with the lotion for use in people with AGA. The study has now been completed and 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 with alopecia areata who used the lotion and got impressive results. It was announced in by Fidia Pharma that the formula from Dr. Brotzu would be marketed under the name “Trinov” and launched in Italy by the end of 2018.
Status: Launching for sale through Italian boutique websites in the beginning of December 2018.
3. Allergan (from Kythera) – Setipiprant is an oral medication or pill. Specifically, Setipiprant is a prostaglandin D2 receptor 2 (PTGDR2) antagonist. Setipiprant was originally developed for medical applications aside from hair growth and has undergone clinical trials for those indications. After George Cotsarelis discovered at UPENN that Prostaglandin D2 potentially plays a major role in hair growth, Kythera began pre-clinical trials with Cotsarelis’ office to determine if PTGDR2 antagonists were worth developing as a hair growth treatment. About two years later, Kythera announced it the rights from Cotsarelis to use setipiprant for hair growth. Since that time, the larger pharmaceutical company Allergan has acquired Kythera and setipiprant with it. Setipiprant is now undergoing a clinical trial.
Points of Interest: Setipiprant has already undergone a phase 3 trial in the US. This has allowed the product to begin at phase 2 in the clinical trial process for androgenic alopecia. Since it is an oral medication it is easy to administer and comply with.
Status: Phase 2A clinial trial has been completed and data is to be announced in 2nd half 2018.
4. – Histogen’s Hair Stimulating Complex (HSC660) 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. The treatment has been trialed on both men and women and is said to be effective at regrowing hair at the 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. In May 2018 Histogen received an IND from the US FDA to trial HSC in female alopecia.
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. After a long drought of news or progress, Histogen announced the initiation of a phase 1 in the US and told a San Diego that a phase 3 trial for commercialization was underway in Mexico.
Status: Phase 3 trial for male AGA has begun in Mexico according to Gail Naughton. Phase 1 trial for female alopecia has begun in Southern California in July 2018.
5. – RT1640 is composed of minoxidil, cyclosporine-A, and a novel molecule RT175. This compound was 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 significant hair regeneration. RiverTown Therapeutics debuted their fantastic hair growth results on Follicle Thought. The three agents in RT1640 act on 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 some of the regenerated hair as well. Interestingly enough, RT1640 was brought to life through its founder’s personal interest in restoring his hair growth. RiverTown was featured in a for the New Yorker magazine in June 2018.
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 is also able to restore pigment to some of the hair it regenerates. The three agents that compose RT1640 have strong safety profiles and have all been tested in clinical trials previously.
Status: Currently seeking investment or strategic partners in order to initiate a Phase 1B/2A study in 2018.6. – SM04554 is a small-molecule topical solution that activates the Wnt pathway to grow hair. In March 2016 Samumed presented their highly anticipated 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. Samumed released a in August 2018 confirming that it will be moving its hair growth topical forward for market approval.
Status: In 3rd Q 2018 Samumed announced it had completed an Investigator Meeting for its upcoming Phase 3 trial for SM04554.
7. – Breezula is a topical anti-androgen developed for the treatment of AGA. Unlike other anti-androgens we have seen which block the body’s production of DHT, Breezula instead works by blocking DHT’s ability to bind to androgen receptors in the hair follicle. It is also claimed that Breezula reduces the skin’s production of prostaglandin D2 (PGD2), a biological compound which, in elevated levels, has been shown to inhibit hair growth. The next reported data from Breezula’s phase 2 dose ranging trial will be very welcomed and should around late 2018/early 2019. Cortexolone-17α-propionate, the active ingredient in Breezula, is also being trialed by Cassiopea to treat acne. In July 2018, Cassiopea issued a describing positive data midway through the phase 2 dose ranging trial.
Points of Interest: Topical anti-androgen with (reportedly) no hormonal side effects. The company states that the drug does not interfere with the androgenic profile of treated patients. Cassiopea has stated the early phase 2 results Breezula produced at 6 months were comparable to oral Propecia’s results in a 12 month trial.
Status: Currently undergoing Phase 2 Dose Ranging Study in Germany with anticipated full data release in early 2019. Cassiopea announced positive midterm data from this trial in July 2018. Expected market launch in 2022.
8. – 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 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 2A trial has been completed in August 2018. Data from that trial is to be announced in October 2018.
9. – Dr. Takashi Tsuji runs one of the most advanced stem cell 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.In June 2018, RIKEN announced their lab is moving forward with animal studies for a newly refined protocol, and if successful they would subsequently initiate human trials.
Status: Currently undergoing research and development with a supposed goal of market release in 2020 if all goes well.
10. – In early 2016, Aclaris acquired the rights from Angela Christiano’s company Vixen to use JAK inhibitors to treat alopecia areata and androgenic alopecia. JAK inibs have shown some amazing results in alopecia areata, sometimes regrowing full heads of. Preclinical research has shown that JAK inibs may have the ability to benefit all types of hair growth. Human trials to address this potential have finally been initiated by Aclaris in Q2 2018.
Points of Interest: JAK inhibitors have shown the ability to push hair follicles into the growth or “anagen” phase; this was by Angela Christiano. Aclaris is currently trialing a topical JAK inhibitor and is also developing a novel “soft” topical JAK inhibitor to be trialed for AGA as well.
Status: Currently trialing ATI-502 in a Phase 2 Open Label study for AGA in both men and women which began April 2018. Data should be released from this study in early 2019.
11. – 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 micro-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 to proliferate 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 within the next several years, which, pending results, could lead to Follica’s hair growth therapy being approved for the market very shortly after that trial. In October 2016 Follica rolled out a new website to showcase the modalities of their treatment and smartphone app. The RAIN, though not fully disclosed yet, stands to be a brief and tolerable procedure.
Status: Aiming at pivotal FDA clearance trial in 2019.
12. – HairClone is a British biotechnology company seeking to regenerate hair through the use of cultured dermal papilla cells. The company has put together an interesting business model while also leveraging scientific innovations and a advantageous regulatory pathway. HairClone envisions patients a few of their hair follicles in a deep freeze storage facility and then utilizing those follicles periodically over the course of years to create cellular cocktails to be injected back into their scalp. This is an innovative approach to cellular hair growth therapy and makes the process of undergoing repeat procedures easier for patients. HairClone anticipates that their cellular therapy will rejuvenate existing hair follicles that have become weakened as well as form new hair follicles. Key leadership for the company includes Paul Kemp PhD, Vincent Ranford PhD, and well known hair surgeons Drs. Bessam and Nilofer Farjo. A news describing the HairClone procedure was reported in 2017.
Points of Interest: The founders of HairClone were responsible for the first company to attempt hair regeneration via cell therapy (Intercytex) in the late 2000’s. HairClone has assembled a robust scientific advisory board including well known researcher Dr. Claire Higgins. The procedure is projected to involve only one surgery to extract 50 hair follicles via FUE, place those follicles into cryopreservation, and use them as needed over the following years. HairClone estimates a patient may want to receive follow-up injections every 2-3 years to maintain optimum hair health. The company is planning on unveiling a campaign sometime in 2018.
Status: Currently working on cellular expansion processes and establishing a hair cloning protocol. Official announcement regarding the company’s crowdfunding campaign is expected October 2018.
On the horizon:
(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 “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. 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.
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