Coegin Pharma to Release Follicopeptide Gel in 2025

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

I covered Follicum (Sweden) and its FOL-005 (now FOL005) hair growth peptide in eight posts between 2015 and 2021. This was prior to the company’s cessation of work on FOL005 and acquisition by Coegin Pharma (Sweden) in 2022. However, this product is now back as a cosmetic called Follicopeptide that will likely be released in 2025. The top half of this post has the most recent updates.

Follicum’s unique osteopontin based hair loss treatment is very interesting. This product can both stimulate scalp hair growth and reduce excessive body hair growth (hirsutism). And the same technology could potentially treat diabetes and inflammation related disorders.

September 11, 2024

Follicopeptide

Coegin Pharma’s INCI application for FOL005 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.

INCI stands for International Nomenclature of Cosmetic Ingredients. A number of companies have in recent years targeted the hair loss market via cosmetics. This includes Kintor via KX-826 (Pyrilutamide); Sirnagen via CosmeRNA; and Yuva Biosciences/Bosley via Revive+ Densifying Foam.

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 FOL005:
Coegin Pharma Follicopeptide (FOL005 from Follicum).
Coegin Pharma Follicopeptide (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 Acqusition 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.

Topical Exosomes for Hair Growth

In 2019 when I first discussed exosomes for hair growth, most doctors were injecting them into the scalp. Recently, I also discussed the rarer intravenous (IV) delivery of exosomes to tackle hair loss. Now I look at the topical application of exosome serums into the scalp, due to three such new products being in recent news.

Note that some injectable products from exosome suppliers to the hair loss market can also be applied topically. The method of delivery will depend on your doctor’s or clinic’s preference.

Calecim (PTT-6) Advanced Hair System with Topical Exosomes

Calecim PTT- 6 Topical Exosomes
Calecim (PTT- 6) Advanced Hair System: Topical Exosomes and Growth Factors for Hair Growth.

Last month, HairClone (UK) announced a partnership in which the company will work with an interesting new exosome containing topical product called Calecim Advanced Hair System (that comes with a Derma Stamp). Edit: The manufacturer has now given blog readers a 15% off discount code “HLC2020”.

This Calecim product includes PTT-6®, which contains over 3,000 proteins, including growth factors, cytokines and exosomes that signal cells to regenerate.

PTT-6 is derived from the secretion of cord lining stem cells isolated from the umbilical cord tissues of New Zealand red deer at birth. No deer is harmed during the extraction and harvest process of this rich source of stem cells.

Calecim Dermastamp
Calecim Dermastamp Included.

The full list of ingredients is PTT-6® and cord lining conditioned media (from stem cell derived fibronectins, glycoproteins, albumin, collagens and hyaluronic acid).

This Calecim topical serum is to be used with an included Derma Stamp for better absorption. A lot people underetrake at-home microneedling for similar reasons. This includes via dermarollers or dermapens or dermastamps.

Elevai Exosomes Combined with Yuva Biosciences Mitochondrial Technology

Elevai Topical Exosomes
Elevai Topical Exosomes for Hair Growth.

Yesterday, reader “John Doe” posted a link to a positive update from Elevai Labs (US) regarding the company’s topical Elevai “age zero” Exosomes™ product range for hair loss. In a year-long study that the company conducted, patients who used Elevai empower™ exosomes in combination with in-office microneedling saw favorable results. The company also makes Elevai enfinity™ for at-home use in repairing your skin.

The 12-month results were assessed using imaging analysis and showed a cessation in crown inflammation, a reversal of miniaturized hairs, and a recovery of hairs from the dormant resting phase. the still on-going research study is being conducted in partnership with Carly Klein, president of the National Hair Loss Medical Aesthetics (NHLMA).

Note that I previously also discussed Elevai in my post on Yuva Biosciences and BosleyMDs new hair loss product related to mitochondrial upregulation. Yuva is partnering with Elevai to release a hair loss product that will combine Elevai’s proprietary PREx™ exosome technology with Yuva’s Y100™ mitochondrial technology. The two companies jointly filed for a combination patent in August 2024.

Ultimately, Elevai is developing a new hair and scalp care product line, called “Elevai S-Series Root Renewal System” that will be powered by exosomes and mitochondrial technology. According to company CEO Dr. Jordan R. Plews, they are in the process of conducting a follow-on study. This will further analyze the combination of Elevai exosomes and Yuva’s Y100 mitochondrial technology to address hair loss and thinning concerns.

ExoCelBio Evovex Serum

Another company that makes a line of topical exosomes is ExoCelBio (US) via its Evovex serum. The company website says that these exosomes are derived from the chorion of placental mesenchymal stem cells (pMSCs). Their Exovex™ serum Refine brand was launched in 2023 and has a concentration level of 75 billion exosomes per vial. Refine employs a high concentration of non-lyophilized, purified exosomes that results in fuller and stronger hair.

In May 2024, the US FDA sent a violation warning letter to ExoCelBio in relation to the company’s marketing and lack of a biologics license. This is not surprising, considering the new stricter FDA guidelines governing exosome products. In the US, exosomes are regulated as both a drug and a biologic. In Europe, you are not even allowed to use human-derived exosomes to treat hair loss.