CD83, Mallia Therapeutics, sCD83

Mallia Therapeutics, CD83 and Hair Loss

137 Comments

Mallia Therapeutics (formerly MalliaBioTech) is a Germany-based company that is developing a novel hair loss treatment based on a soluble version of the CD83 protein (i.e., sCD83). The bottom of this post is my original 2021 write-up about this company, with new updates on top.

Update: September 15, 2025

Recently, someone from a company that handles Mallia Therapeutics’ communications e-mailed me the below update:

“I wanted to share a quick but substantial update on Mallia, which you last covered back in May. Since then, Mallia has undergone a strategic reorganization and is now operating as a holding company, Mallia Innovations GmbH, with two subsidiaries focusing on therapeutic and cosmetic applications of its sCD83-based technology platform.

The therapeutics arm, Mallia Therapeutics GmbH, continues to advance MAL-856, a drug candidate based on sCD83, aimed at treating various forms of alopecia as well as wound healing. The company is planning to advance the therapeutic candidate toward clinical trials.

At the same time, Mallia has launched a second subsidiary, Mallia Aesthetics GmbH, to develop innovative cosmetic applications for hair growth based on a related molecule, MAL-838, which is also derived from sCD83. Their focus is on establishing a line of hormone-free, science-backed cosmetic products under the name 8T3 that are based on the mode of action of sCD83. The launch of the first 8T3 products is planned for 2025, with the goal of making advanced, research-driven solutions accessible to both professionals and consumers.

To support the build-out of both subsidiaries, Mallia recently completed a 5.5-million-euro seed financing round. The capital will primarily be used to bring the cosmetic product line to market while continuing development work on the therapeutic candidate.

The company has also formalized two advisory bodies. A corporate Advisory Board now includes Jens Holstein (former CFO of BioNTech), Dr. Alexandra Ogilvie (dermatologist and digital opinion leader), and Dr. Ulrich Dauer (serial biotech CEO). In parallel, a Scientific Advisory Board has been established, featuring leading experts in dermatology, translational research, and hair biology, including Prof. Dr. Ulrike Blume-Peytavi, Dr. Claire A. Higgins, Dr. Gillian Westgate, Dr. Geert Cauwenbergh, and Prof. Dr. Franklin Kiesewetter. These groups will provide strategic and scientific guidance as Mallia advances both clinical and consumer-facing programs.

With the new structure, Mallia wants to deliver on its original therapeutic vision while expanding into the cosmetics space for rapid market entry.”

Update: May 28, 2025

Mallia Therapeutics: 8T3 for Hair Regeneration

It seems like Mallia will soon release two cosmetic hair loss products that are based on the ingredient MAL-838 (a formulation of the soluble CD83 protein):

  • 8T3 Essentials for at-home use.
  • 8T3 ProLine for profession use.

Note that they also have a page on MAL-856, which is described as “a structural variant of the extracellular domain of the membrane bound form of CD83 (mCD83).” Both alopecia areata and androgentic alopecia are mentioned on that page. It is unclear whether the company still plans to conduct clinical trials and release a stronger non-cosmetic product in the future.

  • Mallia Therapeutics will participate at the 2025 annual meeting of the European Hair Research Society (EHRS) in Warsaw, Poland from May 29 to 31, 2025. Their presentation is titled “Soluble CD83 as a novel therapeutic approach for the treatment of alopecia.”
  • Also of note, in February 2025, Mallia Therapeutics and Northway Biotech (Lithuania) announced a partnership for the development of the production process and manufacturing of Mallia’s soluble CD83 protein (sCD83). Northway is a biologics Contract Development and Manufacturing Organization (CDMO) with facilities in the US and Lithuania.

Update: June 18, 2024

Mallia Therapeutics expects to start 150-person clinical trials at the beginning of 2025.

Update: July 11, 2023

Mallia Therapeutics Secures Seed Funding

Mallia Therapeutics (previously MalliaBioTech) finally has a website. Moreover, the company just announced that it has secured seed funding. They now plan to raise Series A funding prior to beginning clinical trials.

The company is developing a soluble CD83 (sCD83) based topical treatment of hair loss.

This sCD83 has an immune-modulatory function and induces hair growth via a dual mode of action:

  • It induces an anti-inflammatory environment around the hair follicles via regulatory T cells (Tregs). These interact with follicular stem cells and activate hair growth.
  • It directly binds to follicular stem cells and induces the formation of new hair follicles. So sCD83 not only prevents hair loss and accelerates growth, but also induces the growth of new hair.

Moreover, this treatment will supposedly work for both androgenetic alopecia (AGA) and the less common alopecia areata (AA).

Key quote (slightly reworded):

“The company is led by world leading experts in the field of CD83, with more than 60 CD83-related publications and 20 years of relevant experience.”

November 4, 2021

A new biotech company in Germany named MalliaBioTech is working on a topical hair loss treatment based on the CD83 molecule.

Mallia Biotech, CD83 and Hair Loss

On October 27, the Friedrich-Alexander University (FAU) in Germany published an important page on their site titled:

“FAU project wins funding for remedies against hormone-related hair loss.”

An soluble CD83 based active ingredient newly developed at FAU leads to new hair growth. The FAU researchers from the Department of Immunomodulation and the Department of Dermatology at the University Hospital Erlangen received the m4 Award for this project on October 21, 2021.

So far, this CD83 (see gene card) based active ingredient has not shown any side effects in pre-clinical studies.

Mallia Therapeutics CD83 Hair Growth
CD83 hair growth before and after. Screenshot from a Mallia Biotech video.

The research team is led by Dr. Alexander Steinkasserer, who I e-mailed for more information. His co-researchers include Dr. Dmytro Royzman and Prof. Dr. Carola Berking. Their new company is called MalliaBioTech, and it received EUR 500,000 via the m4 Award. It is officially called the m4 Award from the state of Bavaria.

“The new product has the potential to conquer the large unfulfilled market of hair loss.”

In contrast to existing hair loss treatments Finasteride and Minoxidil, this topical treatment based on a soluble form of the CD83 molecule:

“Stimulated the formation of new hair follicles and thus induces new hair growth.”

While the current pre-clinical work is in mice and yet to enter human clinical trials, this research represents yet one more new method to tackle androgenetic alopecia. We read about at least five such major new hair loss cure related discoveries every year, so reader skepticism is warranted.

When I first heard about CD83 for hair growth, I assumed it would be for alopecia areata. This is due to the frequent use of the word “immune” in tandem with CD83. However, the new German research clearly indicates that this treatment will also work for hormonal hair loss (aka androgenetic alopecia).

Coegin Pharma, FOL-005, Follicum, Osteopontin

Coegin Pharma to Release Follicopeptide Gel in 2025

105 Comments

Update: September 11, 2025

Coegin’s Follicopeptide to be Released in Sweden in December 2025

True to its word, Coegin Pharma (Sweden) will release Follicopeptide in Sweden in December 2025. It has partnered with premium grooming retailer Gents (Sweden) via a distribution agreement. The launch will occur via both Gents’ website and its flagship stores in Sweden.

For a history of this osteopontin-derived peptide product, make sure to read all my past updates below; as well as my many past posts on Follicum (written between 2015 and 2021). The latter company first developed Follicopeptide (as FOL-005), before being acquired by Coegin in 2022. Follicopeptide represents yet another very unique hair loss cosmetic product released in the past several years after Sirnagen’s CosmeRNA; Kintor’s KX-826; and Bosley plus Yuva Bioscience’s Revive+ Densifying Foam.

Update: May 9, 2025

Coegin Pharma has released a Question & Answer section on its website based on people’s questions regarding Follicopeptide (for hair growth) and NPP-4 (for skin tanning). The former is planned to be launched in Europe as a cosmetic by the end of 2025. Follicopeptide is the name for FOL-005, which was originally developed by Follicum (acquired by Coegin in 2022).

Key quote with some language modification by me:

“In a large study, once per day application of Follicopeptide led to an average increase of 7-12 new hairs per cm2 after four months. Over 70% of users responding positively to treatment.“

Note that this average of 9.5 hairs per cm2 is higher than the 6.6 hairs per cm2 obtained in Follicum’s Phase 2 trial results for FOL-005 in 2021.

Coegin Follicopeptide
Coegin Follicopeptide. Mockup image of potential future products from Coegin’s Twitter account.

September 24, 2024

Coegin Pharmahas has signed a joint development agreement with Scandinavian Biolabs to develop a portfolio of products based on FOL-005 for hair growth. Initial product launch is expected in the second half of 2025. Scandinavian Biolabs already has a presence in the hair loss world via its Bio-Pilixin hair strength shampoo, conditioner and hair activation serum.

September 11, 2024

Follicopeptide

Coegin Pharma’s International Nomenclature of Cosmetic Ingredients (INCI) application for FOL-005 was approved at the end of May 2024. The hair loss cosmetic gel will be called FollicopeptideTM and is being prepared for a global launch. The key ingredient will be listed as “sh-Oligopeptide-128 SP”. For more details, see Coegin’s pipeline page. Per the company’s Twitter announcement image, they will produce a range of products containing Follicopeptide.

August 12, 2024

Coegin Pharma has signed an agreement with the University of Bradford (UK) to commercialize groundbreaking hair and skin pigmentation peptides. Their goal is to release a topical self-tanning product based on the peptide NPP-4 as early as 2026.

October 25, 2023

Coegin to Release FOL005 Hair Growth Peptide Gel in 2025

Some major new updates since I wrote the summary earlier this year (see second half of this post).

“After carefully analyzing the possibility of launching FOL005 as a cosmetic product line, we have come to the conclusion that it is an opportunity with great potential. This will minimize development risk, significantly reduce capital requirements and strengthen commercial opportunities in the short and long term. We have therefore revised our strategy and now aim to launch FOL005 as a cosmetic product series as early as 2025 with the USA as the first market.”

It seems like CosmeRNA started a great new trend. No more ten year clinical trials and failure to come to market.

  • Follicum’s website was temporarily restored and updated very recently. The milestone plan page has a detailed chart for FOL-005:
Coegin Pharma Follicopeptide (FOL005 from Follicum).
Coegin Pharma Follicopeptide (FOL-005 or FOL005 from Follicum) milestone timeline.

April 8, 2023

Follicum Past Clinical Trials

I covered both of Follicum’s past clinical trial results in 2017 and 2021, respectively.

  • In 2017, Follicum’s Phase 1 clinical trial results were released. They were deemed as positive (8 percent increase in hair growth), with an effect comparable to that of Minoxidil. Moreover, safety was not an issue, with no major side effects in trial participants.
  • In 2021, Follicum’s Phase 2 clinical trials of FOL-005 came out. The topical compound resulted in a 6.6 hair/cm2 increase in hair growth, but this was deemed to be insignificant compared to placebo.

Thereafter, the company ceased further development of FOL-005, and it all seemed over for yet another false flag operation. Or perhaps not?

Merger and Acquisition by Coegin Pharma

In September 2021, Coegin Pharma merged with Follicum. This merger was confirmed as an acquisition in 2022.

In the first of the two links above, Coegin’s CEO Tore Duvold said something of interest in the interview:

Question: “With regard to the hair loss project, which has recently been put on hold, how will it be handled once the companies merge”?

Answer: “Follicum announced that they have paused the hair loss project. In Coegin, we have strong capabilities in dermatology, and we will review and analyze the results before we make any conclusions”.

Follicum Back in the News

  • In March, a Tweet from Coegin indicated that they were meeting with potential partners for Follicum’s FOL-005.
  • Follicum was mentioned in February in an updated article titled: “Could We See a New Dawn for Hair Loss Treatments?”. It summarizes the problems that the company faced in trying to bring FOL-005 to market after the unimpressive Phase 2 trial results.
  • When going through Coegin Pharma’s website, I found a highly detailed comprehensive corporate presentation on Follicum and FOL-005. It was presented at the end of 2022 by Coegin’s COO Kristian Lykke Fick.

Their take on the past trials is more positive. Key quote:

“FOL005 1.5% dose was on par with treatment effect reported for minoxidil and finasteride with a growth of 12 hairs/cm2 after 4 months of treatment. However, with more than 60% of subjects responding to treatment compared to competitors where 40% responders effect is previously documented after 4 months.”

Note that Follicum’s old Swedish website is being routed to the English site that has an expanded research section on FOL-005. In 2022, they also filed for a patent related to wound healing. I am surprised they do not mention anything in relation to their osteopontin-derived peptide’s body hair growth inhibition.

Follicum plans to conduct various new scalp hair growth related clinical trials from 2023-2027. On their website’s plans section, they state the following:

“We believe there is a high likelihood of success based on the previous clinical data.”

Too bad about the new time frame and the wait for venture partners for funding. Otherwise, I am not entirely pessimistic about this product. I do feel that it can compete with Finasteride and Minoxidil in terms of effectiveness, but via a totally different mechanism of action. And with no serious side effects.

Follicum’s frequent press releases, CEO Jan Alenfall’s presentations, and the company’s rapid clinical trial progression impressed me. Their chief business officer Gunnar Gårdemyr was also in regular communication with me in the past.