Ultimate Guide to Hair Regeneration Pipeline 2023
Updated October 2023
This post contains a list of the most viable and relevant hair regeneration treatments which are in development. They can be referred to as hair loss cures, baldness cures, hair growth treatments, hair loss treatments, or cures for androgenic alopecia. The treatments listed in this guide are ranked by a combination of their estimated hair growth potential and estimated release date to the public market. Ranking #1 is the most relevant and so on. Rankings on the list are always subject to change depending on information that becomes available. Directly below is a pipeline chart of the most clinically developed therapies in the hair growth industry, plus a few selected promising therapies. The estimated launch dates range from a “best case scenario” to a likely scenario. Naturally, all estimated launch dates are contingent upon the treatment passing efficacy and safety in clinical trials.
1.Kintor Pharmaceutical– Kintor currently owns two of the more interesting AGA therapeutic candidates within their pipeline, pyrilutamide and GT20029. Pyrilutamide is a topical androgen receptor antagonist which is being trialed in both androgenic alopecia and acne by Kintor. This would put it in the same category as the drug Breezula. A published patentapplication(p. 85)for pyrilutamide claims that it outperformed known AR antagonist RU-58841 in a preclinical study to evaluate hair growth effect. Pyrilutamde may be the most potent AR antagonist currently in development for AGA. On February 1, 2021, Kintorannouncedits newer drug for hair growth, GT20029, which may potentially provide several benefits over existing anti-androgen hair drugs including pyrilutamide. Among them, Kintor claims that GT20029 may: 1) reduce the sensitivity of androgen receptors to androgens without systemic exposure to the drug, 2) maintain efficacy with small local administered amounts of the drug which can reduce dosing frequency compared to other small molecules, and 3) demonstrate greater efficacy than other AR small molecules without excessive drug accumulation and notable side effects.” Kintor plans to develop and launch both of these drugs in both China and the US.
Points of Interest:Kintor Pharmaceutical is publicly traded company on the Hong Kong stock market and has no problems financing both of their drugs pyrilutamide and GT20029 through clinical trials in both China and the US. Kintor’s newer drug for hair, GT20029, is a more advanced technology called an AR degrader which could pose less of a risk for potential systemic side effects. In August 2022, Kintor shared data from its phase 2 male pyrilutamide trial showing an increase of 22 non-vellus hairs above baseline.
Status:A Phase 3 trial of pyrilutamide in China completed enrollment in March 2023 and is expected to read out data in Q4 2023; a US Phase 2 trial shared data in May 2023. An additional long term safety Phase 3 trial began in China in July 2023. This pushes the potential release date of pyrilutamide back into late 2024/early 2025 in China. A Phase 2 trial of pyrilutamide for females in China released data in December 2022.
A Phase 2 trial of GT20029 completed patient enrollment in August 2023 in China, while a US Phase 1 trial released positive safety data in February 2023.
2．TechnoDerma Medicines–TechnoDerma’s TDM-105795 is one of the latest new drugs to enter clinical trials for AGA in the US. The company initiated a phase 1 safety trial in April 2021 and a follow upphase 1b trialin February 2022. TDM-105795 is classified as a topical thyroid hormone receptor agonst aka a thyromimetic. In other words, it’s a drug which mimics the activity of thyroid hormone.
Points of Interest:The lead candidate in TechnoDerma Medicines’ pipeline is TDM-105795 for AGA. This topical drug could replace or augment the use of the “gold standard” hair growth drugs, finasteride & minoxidil. The upcoming phase 2 trial results will be an important moment for the industry to gauge the potential of this new chemical entity to treat pattern hair loss.
Status: TDM-105795 was initiated into a Phase 2 trial in April 2023 which is estimated to complete in Q1 2024.
3.Epibiotech (Stemore)– Epibiotech is a biotechnology company from South Korea which is a developing a wide range of therapies for hair loss. The company was founded by Dr. Sung Jong Hyuk of Yonsei University. Epibiotech’s primary target is creating an effective dermal papilla cell therapy. Dr. Sung and his team have completed numerous studies ondermal papilla enhancementandadipose-derived stem cell enhancement．In late 2019, Epibiotech completed anexclusive interviewwith Follicle Thought which explained the company’s therapies in great detail.
Points of Interest:Epibiotech has multiple therapies in theirpipelineincluding topical drugs for hair growth. The company’s technology specializes in maintaining the hair growth capacity of dermal papilla cells, even after being cultured multiple times, which has previously been thought to be the major hurdle of DP cell therapy.
Status: Has filed an IND to begin a clinical trial for its dermal papilla cell injection therapy in Korea in 2023. In September 2023, Epibiotech CEO told Follicle Thought that a trial would begin by the year’s end.
4.Cutia Therapeutics–Cutia entered the the hair growth field scene in 2022. The company is an R&D pharma startup with a focus on dermatology and aesthetics. Its candidate therapeutic for hair growth is called CU-40101.
Points of Interest:Cutia Therapeutics has quietly entered the clinical trial level. The company appears to be affiliated with the massive Chinese pharmaceutical company Wuxi Apptec, which is promising for resources and support. Cutia’s CU-40101 is, in fact,licensed from Technoderma Medicines(p. 12), and is the same molecule as TDM-105795. Cutia has licensed TDM-205795 for its development in the Asian territory. Aphase 1 trialis expected to complete in November 2023.
Status: A Phase 1 clinical trial in China began in August 2022 and is expected to complete in late 2023.
5.Hope Medicine– HMI-115 is Hope Medicine’s lead candidate compound, and is also its therapeutic for AGA. Hope Medicine is based in China and has licensed its hair growth technology from the global pharmaceutical Bayer AG. HMI-115 is a prolactin receptor (PRL) antagonistic antibody.
Points of Interest:The genesis of this compound involving Bayer AG is an interesting and promising story. In 2019, Hope Medicineissued a press releasedetailing impressive results for HMI-115 in a stump-tailed macaque study which was said to be “nearly doubling the number of terminal hairs after 6 months even in previously fully bald areas and showing a sustainable impact even after 2 years post treatment.” In January 2022, a press release was issued announcing that Hope had received IND approval for a phase 2 trial in androgenetic alopecia in the US. Aphase 1 trialin Australia began in May 2022 for both males and females with AGA.
Status:美国的印第安纳州2期临床试验批准在2022 and a Phase 1 trial was initiated in Australia in May 2022. The Phase 1 trial is estimated to have completed enrollment in July 2023, and is likely full completed as of October 2023.
6.Moogene Medi– Moogene Medi is a Korean company developing topical therapeuticswhich are delivered through a proprietary system comprising lipid nanoparticles, microbubbles, and ultrasound. While the company initially intended to develop aCRISPR therapyfor androgenetic alopecia which cut out the gene responsible for producing 5-alpha reductase (the enzyme which creates DHT), it has now switched its focus to the delivery of finasteride and dutasteride due to regulatory hurdles. The current treatment approach is calledHUTERA．The CRISPR therapy for AGA is still a potential if/when a territory which would welcome it for clinical trials is found.
Points of Interest:Moogene Medi’s HUTERA treatment system delivers around 20x more of an active substance (e.g. dutasteride) to the dermis layer compared to dutasteride in a topical alcohol solution. HUTERA also showed comparable blood serum levels of dutasteride, compared to topical dutasteride in a alcohol solution, however HUTERA intends to be used around once per week which could limit side effects and create an advantage. Since HUTERA is based on approved drugs, i.e. finasteride and dutasteride, it could have a fast path to market, taking around only one year.
Status: Preparing for a clinical trial asap (~2024) in Korea.
7.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 procedurehere．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 2014Shiseido 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 itsown scientistswho 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 trialed Replicel’s RCH-01 in Japan from mid 2016 – 2018. Since then, no results from the trial have been shared by the company which has brought about speculation on its outcome. Shiseidoannounced resultsin 2020 which were mildly underwhelming; it also launched a follow up clinical trial in 2020, this time including multiple injections of RCH-01 to get a better idea of efficacy potential. Thattrialis still ongoing and recruiting and will likely complete in 2023.
Status: Currently undergoing a new Shiseido trial in 2022 with multiple injections to get a more complete idea of RCH-01’s potential as a hair regrowth therapy. As of October 2022, the trial is still listed as recruiting with a total number of participants set at 36.
8.Cosmo Pharmaceuticals (Cassiopea)——Breezula局部从品牌名称的ndrogen developed by Cassiopea for the treatment of AGA. The actual drug itself is called clascoterone and is also used to treat acne. 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. Cortexolone-17α-propionate, the active ingredient in Breezula, is also being trialed by Cassiopea to treat acne. In July 2018, Cassiopea issued apress releasedescribing positive data midway through the phase 2 dose ranging trial. In April 2019 anotherpress releasewas issued detailing the fully completed 12 month trial.
Points of Interest:Clascoterone/Breezula is a topical anti-androgenwith (reportedly) no hormonal side effects. The company states that the drug does not interfere with the androgenic profile of treated patients. Cassiopea also stated the early phase 2 results Breezula produced at 6 months were comparable to oral Propecia’s results in a 12 month trial. In June 2023, apress releasewas issued announcing the start of a phase 3 clinical trial for Breezula in male patients. The phase 3 trial will include two 6 month phase 3 trials, whereas after the first 6 month trial, participants which are deemed as responders to the treatment will enter an additional 6 month trial to receive either more clascoterone or placebo. Full study details are listed onClinicalTrials.gov．
Status:一个男性AGA是initia的3期临床试验ted in June 2023 and is estimated to complete in early 2025.
9.HairClone–HairClone is a British biotechnology company seeking to rejuvenate 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 patientsbankinga 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. The company also anticipates that cellular injections could convert DHT-susceptible follicles into DHT-resistant follicles.Key leadership for the company includes Paul Kemp PhD, Vincent Ranford PhD, and well known hair surgeons Drs. Bessam and Nilofer Farjo. A newsvideodescribing the HairClone procedure was reported in 2017.
Points of Interest:的创始人HairClone负责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. Its procedure is projected to involve only one surgery to extract ~100 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 unveiled acrowdfundingcampaign in 2018 which did not meet its goal. After the failed crowdfunding attempt, HairClone secured a few government grants to continue its development in 2020. After global delays incurred in 2020, HairClone continues to further its program into a small scale investigative operation in the UK.
Status: Undergoing preclinical research to create a GMP licensed facility/process for the purpose of expanding dermal papilla cells. As of October 2022, HairClone is still seeks to offer expanded cell treatments to practitioners in the UK ASAP, with H1 2023 as a potential.
10.Tsuji/Riken- OrganTech– Dr. Takashi Tsuji runs one of the most advanced stem celllabsin the world at the Riken Institute in Japan. 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. Many people have speculated that this type of hair cloning technology could be a holy grail baldness cure.
Points of Interest:教授一直在研究毛囊2022世界杯附加赛预测veral 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. In early 2021 Dr. Tsuji announced a crowdfunding initiative to move his project into human trials. After an apparent setback in late 2020, the Organ Technology company has re-emerged in 2023 as “OrganTech”, and announcedinvestmentfrom Kobayashi Pharmaceutical Co.
Status: The re-invigorated OrganTech company aims to enter clinical trials in 2024, although with no firm evidence for achieving that as of October 2023.
11.Stemson Therapeutics– Stemson Therapeutics is a hair multiplication company based in La Jolla, CA. The company has been founded by Dr. Alexey Terskikh who is known from his research on hair cloning at the Sandford Burnham Prebys Institute. Thefirst iterationof Terskikh’s research in hair cloning made headlines in 2015 when he was able to grow hair on mice using human induced pluripotent stem cells which were converted into dermal papilla cells. In 2019, the Sanford Burnham Prebys Instituteannouncedthat Terskikh had created a separate company (Stemson) to further develop his hair cloning research into a commercial therapy. The company now stands as North America’s front runner in the hair cloning industry. CEO Geoff Hamilton hastold the mediathat Stemson is hoping to begin human trials within the next few years.
Points of Interest:Stemson claims that they only need a small tissue sample from a patient, even blood, to create an unlimited supply of hair producing “folliculogenic” cells. In June 2019, Stemsonannouncedit had received a $3 million investment from the pharmaceutical powerhouse Allergan. Stemson also claims that it will be possible in the future to create allogeneic treatments with their technology. This means a patient will not need to harvest their own cells to produce the folliculogenic cells and could simply receive injections from a compatible cell line developed by Stemson.
Status:Currently developing a hair multiplication therapy using all human cells and a biodegradable scaffold which guides the direction of hair growth through the skin. Aiming at human trials asap (~2025).
12.Tissuse/J. Hewitt——TissUse的头发乘法技术”聪明Hair Transplant” or SHT has been licensed to the biopharmaceutical company J. Hewitt of Japan. Through this agreement J. Hewitt has rights to develop and commercialize the SHT procedure in Japan where regulations allow stem-cell based technologies to reach the market faster than anywhere else in the world. In September 2019, CEO of J. Hewitt, Jon Knight,told Follicle Thoughtthat his company had ambitious plans to get SHT into a clinical trial quickly and “prove to the world” whether the treatment works. If successful, SHT would change the current paradigm of hair restoration. In the SHT procedure, 30 hair follicles are first extracted from the donor area of the scalp. Specific cells are isolated from the extracted follicles and then put through TissUse’s proprietary culturing technique. The company theorizes that from 30 hair follicles the SHT procedure can create 10,000 “neopapillae.” The neopapillae are hair promoting cells which are capable of growing new hair follicles and rejuvenating existing weakened hair.
Points of Interest:TissUse’s technology was developed by world-class hair follicle researchers Drs. Gerd Lindner and Roland Lauster. Their initialscientific paperon hair multiplication was published in 2011 and the technology has been continuously refined since then. If and when a clinical trial is initiated in Japan, pending success, the SHT treatment could have an abbreviated path to market due to Japan’s regenerative medicine regulations.
Status: After facing many delays due to global health conditions, J Hewitt continues to seek a manufacturing partner to embark on a landmark cell therapy clinical trial in Japan.
No Longer On The List:
Follica– 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 platform was originally called R.A.I.N. or regeneration abrasion induced neogenesis. In 2019 the treatment was officially titledFOL-004in the company’s press releases. FOL-004 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. Follica’s website, at one time, has also shown 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’s next step is to initiate a pivotal trial, which, pending results, could lead to Follica’s hair growth therapy becoming market approved shortly thereafter. The in-office portion of the FOL-004 treatment is reported to take only 5 minutes. In 2019, Follicaannouncedpositive results, a “44% improvement of non-vellus hair count”, from a clinical study with male participants.
Status: After announcing positive clinical results in 2019, the FOL-004 clinical program appears to be on hold as of October 2022. The next announcement would be the initiation of a pivotal trial for FDA approval of its drug + device combo. As that announcement does not appear to be imminent, Follica has been removed from the active list.
Biosplice Therapeutics (formerly Samumed)– SM04554 aka Dalosirvat is a small-molecule topical solution that activates the Wnt pathway to grow hair. In March 2016 Biosplice/Samumed presented their highly anticipatedphase 2 resultsat the American Academy of Dermatology. The Phase 2 results got a mixed response from the online world of hair growth enthusiasts, but ultimately, the treatment did grow hair in the trial. The best responding group from the trial showed an approximate 10% overall increase in hair density. This phase 2 trial also lead to the conclusion that SM04554 does not create a “dose response” in patients who use it. This means that adding more of the drug to a patient’s biological system does not lead to increased results. Finding the “just right” dosage and application is important for this drug to work its best.
Points of Interest:Biosplice/Samumed began by breezing their way through clinical trials and completed an important phase 2 within about two years time from their initial startup. The company has even reached the phase 3 level for its drug which is rare in the alopecia field. Thephase 3 trialfor SM04554 began in November 2018 and is scheduled to complete in January 2021.
Status: Biosplice has completed a Phase 3 trial for SM04554 in Turkey in January 2021. Since then, the company has taken the SM04554 program off of its website and told patients via email response that it is no longer developing the therapy internally and seeking a partner for the drug, which is an unlikely outcome.
Histogen– Histogen’s Hair Stimulating Complex (HST-001) 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 inclinical trials．The treatment has been trialed on both men and women and is said to be effective at regrowing hair at thetemplesas well as throughout the scalp．最初的《盗梦空间》相比,当前的HSC product has been refined over the past few years to contain less cellular impurities and be a more concentrated formula of growth factors. After a long drought of news or progress, Histogen carried out a phase 1female trialin the US in 2018.
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. If a larger pharmaceutical company (such as Allergan) would be interested in partnering with Histogen, the HST-001 product would likely speed through clinical trials and become a highly successful product. It could be implemented in offices that offer aesthetic injectables such as botox or collagen.
Status: Results from a Phase 1B for men were announced in February 2021 showing that HST-001 did not show a statistical significance over treatment with placebo. On June 3, 2021, Histogen announced that it is suspending the development of HST-001.
Follicum–Follicum is a Swedish biotechnology company that is developing human peptides for the use of stimulating hair growth, and potentially inhibiting hair growth. The lead candidate peptide of Follicum’s pipeline is called FOL-005. In its first clinical trial the peptide was tested on the thighs of human patients and displayed an increase in hair growth in the treated areas. FOL-005 was subsequently tested in aphase 2 trialon human scalps by injection delivery. That trial showed FOL-005 was able to create an average increase of 7 hair per cm² among the trial subjects. Follicum has since developed a topical cream-like version of their peptide to make the treatment more user-friendly. In 2020, a topical version of FOL-005 will be tested on human scalps and will be a decisive moment for the potential hair growth drug.
Points of Interest:Follicum debuted agraphof FOL-005’s pre-clinical trial results on Follicle Thought, which were impressive. Follicum has been working with renowned hair researcher Ralf Paus since 2012 to further their R&D. In late 2019, Follicum announced that a topical formulation of their peptide has been completed through collaboration with Bioglan and is ready to be trialed.
Status: A Phase 2A trial using a topical version of FOL-005 we completed in early 2021 and the results did not show positive statistical significant compared to placebo, thus, their program for hair growth has been dropped.
Rapunzel–Two of the most prominent names when it comes to hair follicle research, Dr. Colin Jahoda and Dr. Angela Christiano, have teamed up to bring an effective hair loss cure to the masses. 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 recentlystated“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 cellsgrew hair on her armall the wayback 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: The company website which never contained a pipeline or much information has now expired, a telling sign for the direction of progress.
RiverTown Therapeutics Inc.– 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 pilot 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 ondistinct pathwaysAGA和协调促进增长和梅ntenance 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 treating his own baldness. RiverTown was featured in apopular articlefor the New Yorker magazine in June 2018.
Points of Interest:Theresults for RT1640 are promising for 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: After years of unsuccessfully seeking funding for an important phase 2 trial, the company has closed its doors.
Aclaris Therapeutics– 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 inhibitors have shown some amazing results in alopecia areata, sometimes regrowing full heads ofhair．Preclinical research has shown that JAK inhibitors may have the ability to benefit all types of hair growth. Human trials for androgenic alopecia were initiated by Aclaris in Q2 2018 and showedpositive results．However, in August 2019 Aclaris announced that is was putting its JAK inhibitor alopecia programs on permanent hold due to the cost and lengthy durations of their associated clinical trials.
Points of Interest:JAK inhibitors have shown the ability to push hair follicles into the growth or “anagen” phase; this waspublishedby Angela Christiano. The companyreleased datain June 2019 showing positive results for treating AGA with JAK inhibitors. In order to reach the market, Aclaris’ programs for alopecia would need to be partnered with a larger pharmaceutical company who will fund the necessary remaining clinical trials.
Status: Aclaris is no longer pursuing development of their JAK drugs for AGA and AA. The only potential way forward for these programs is to partner with a larger pharmaceutical company, which is unlikely.
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 itacquiredthe 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 aphase 2Aclinical 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: After a phase 2a trial did not show significant results, the program appears to have been dropped by Allergan.
Fidia Pharma–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 aclinical studywith the lotion for use in people with AGA. The study has now been completed andFidia has saidthe 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 ayoung girlwith alopecia areata who used the lotion and got impressive results. It was announced inSeptember 2018by 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: After keeping many people’s levels of interest high for several years, the formula hit the market and received less than praise from many of its users. After an underwhelming response from Trinov users it does not meet the criteria to be listed on the Ultimate Guide anymore.
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