European Correspondent

Research: Examining hair loss and the outlook for 2021

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Samumed – The San Diego-based biotech of Turkish origin, Samumed, currently owns the most advanced drug for hair loss problems. Samumed’s wnt activator SM04554 is undergoing a phase 3 clinical trial in Turkey with an estimated completion date of January 2021, according to the page. While the drug is not intended to be a powerhouse, it may be a valuable add-on treatment or alternative to currently approved drugs if approved.

SM04554. Breezula – This androgen receptor antagonist from Cassiopea is currently the second most advanced drug in the hair growth industry. A phase 3 study was expected in 2020, but due to the unexpected events of 2020, the study was postponed and is expected to start in the first half of 2021. Cassiopea also has an ongoing Phase 2 study for female patients using Breezula that is expected to report data in the second quarter of 2021.

Follicum – Another late-stage topical drug, FOL-005 from Follicum, will report key phase 2 trial results in the spring of 2021. This study is especially important for Follicum as it is the first time that the peptide FOL-005 has been topically tested on androgenic alopecia patients (hereditary hair loss). before a larger industry partner comes along to bring the drug to market for approval in a pivotal phase 3 trial.


Shiseido – Shiseido’s surprising follow-up trial of RCH-01 is expected to end in the fourth quarter of 2021, but there is no guarantee we will see the data next year. This time, the trial involves multiple injections of dermal sheath cup cells over 12 months. Hopefully, meaningful results will be seen this time.

HairClone – While HairClone will not technically offer a treatment itself in 2021, it is largely certain that the company will be ready to supply cultured / expanded dermal papilla cells to doctors in the UK who can use the cells to treat patients in 2021. A few timely government grants in 2020 were able to keep HairClone afloat and move towards their goal of human application in 2021.

Kintor – As of December 29, 2020, Kintor has completed enrollment in a Phase 2 clinical trial testing 120 male patients in China. The trial involves multiple dose cohorts and is conducted over a 6-month period. According to Kintor’s latest press release, “The Group expects to complete the clinical study report (CSR) and release the data for the phase II clinical trial in 2021 and a phase III clinical trial (for pyrilutamide) in the second half of 2021 to start.” Kintor sounds great at the moment, let’s hope they live up to their forecasts.

Stemson – While a clinical trial for Stemson is possible in 2021, it’s more likely we’ll get a timeline for a clinical trial with Stemson sometime in 2021. Stemson is the only current active hair augmentation company in the US and has recently made a $ 7.5 million investment from Allergan and a UK firm to get their program started.

Triple Hair TH16 – The all-natural OTC (over-the-counter) in the Triple Hair pipeline. TH16, is expected to be released in the first quarter of 2021, according to the company’s website. According to the company, TH16 outperformed 5% minoxidil in human patients in a self-sponsored clinical trial. While specific details have not been disclosed, some decent looking photos were shared in an exclusive article in ‘Follicle Thought’. The main ingredients of TH16 are said to be reservol and melatonin, two compounds that have been shown to support hair growth in laboratory studies. The formula is marketed for both men and women. Stay tuned for further updates direct from Triple Hair Management in Q1 2021.

University of Wisconsin Hair Cap – Hair Cap – In September 2019, news came out from the University of Wisconsin that a unique new wearable device could become a new useful treatment for hair growth. No news up to now.

Hans J. Diks, European editor International Hair Authority, Independent expert on hair problems.

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