Amplifica, Hairy Moles, Osteopontin and SCUBE3

Amplifica Pipeline
Amplifica Pipeline of Injectables for Hair Growth.

Among newer companies involved in trying to cure hair loss, Amplifica (US) is particularly interesting. It was co-founded in 2020 by Dr. Maksim Plikus and Dr. William Rassman, both of whom I have covered many times before. The company’s two main areas of product development involve hairy mole related protein osteopontin and the SCUBE3 signaling molecule. The top half of this post has the most recent updates.

Update: August 12, 2026

Amplifica Raises $26 million in Series B Preferred Stock financing

Amplifica is still alive. It just raised $26 million in a Series B Preferred Stock financing round. Of particular note, one of the investors is Eli Lilly (US), which also invested in Absci (US) earlier this year.

Note that when I originally wrote this post in 2022, Amplifica completed a $11.8 million Series A Financing round. Scroll till the bottom of this post to read about that development.

Update: August 26, 2025

Amplifica just published 5-month results of a 61-person trial of AMP-301, described as a novel polysaccharide. I think this is the same trial whose results were covered last year (see my September 2024 update below)? The male subjects (all aged 18-45) with mild to moderate androgenetic alopecia (Norwood III-IV) were divided into two groups:

  • Group 1 (n=32): balding duration of 3-5 years.
  • Group 2 (n=29): balding duration of ≥ 10 years).

They all received AMP-303 injections on one side of the scalp in 20 frontotemporal locations, and saline injections on the other side. For the Group 1 responders, the mean increase in nonvellus hair count was 14.5% and it peaked at 60 days. The results remained significantly greater than saline through 5 months.

AMP-303 showed durability of effect with 1 injection cycle and led to hair terminalization. Unfortunately, nothing is said about the Group 2 responders who had been balding for 10 years or longer.

Update: September 30, 2024

Encouraging Results from Amplifica’s First-In-Human Trial of AMP-303

Amplifica’s AMP-303 Phase 1 trial results have come out, and it is very good news.

“A statistically significant percentage of study subjects showed a greater than 15% increase in non-vellus hair count from baseline compared to placebo at 60 days post-treatment, and a greater than 10% increase compared to placebo at 150 days post-treatment.”

Moreover, there were no major safety issues from the intradermal injections, and just a single AMP-303 treatment cycle increased non-vellus hair count. In addition, the increase in hair density and thickness was sustained over time (150 days post treatment).

Best of all, the results demonstrated AMP-303’s ability to transition vellus hairs into non-vellus hairs. This implies not just hair thickening, but also the far more difficult hair loss reversal.

Update: July 12, 2023

An interesting take in Wired magazine on this same hairy mole (aka nevi) and hair growth research. They connect it to the well known phenomenon of dormant senescent cells and aging.

Update: June 28, 2023

Amplifica Begins Clinical Trials for AMP-303

Amplifica just announced that it started clinical trials for its lead candidate AMP-303. The first human subject was given a dose on June 27, 2023 and the study will finish in the first quarter of 2024. According to CEO Frank Fazio:

“Aside from assessing AMP-303 in subjects with androgenetic alopecia, this study will serve as a strong foundation for subsequent clinical studies with Amplifica’s pipeline compounds.”

We already know at least three compounds or molecules that they will likely test in clinical trials (with more to come):

  • Osteopontin = AMP-203 per the DermWire interview I linked to previously.
  • SCUBE3 = AMP-601 per my January 2023 update.
  • CD44 = AMP-303? Not clarified in this latest press release.

Update: June 21, 2023

Amplifica Osteopontin (Hairy Mole Molecule) Clinical Trials Beginning Soon

Hairy Moles Osteopontin
Hairy moles, osteopontin and hair growth.

I previously (see bottom of this post) covered Amplifica and its hairy mole research. The company’s founder Dr. Plikus and his research team discovered that a molecule called osteopontin is primarily what makes hairy moles grow hair.

Morover, this molecule can induce hair follicle growth when administered anywhere on the skin. The initial work was on mice, but the company plans to begin human clinical trials later this Summer per the latest update from today in Insider magazine. Dr. Plikus believes that this compound:

“Could be needled into the scalp of balding men and women to reawaken hair follicles that have gone dormant, in a near-painless Botox-like procedure.”

The treatment and trials will likely involve a combination of osteopontin and some other, newly-discovered hair-growing proteins that Plikus and his team have found. The Insider article implies that the other molecule will be SCUBE3 (already tested via microinjections in mice).

The team’s latest findings in relation to hairy moles and osteopontin were published in Nature magazine: Signalling by senescent melanocytes hyperactivates hair growth.

The study describes the essential role that the osteopontin and CD44 molecules play in activating hair growth inside hairy skin nevi. In addition to these two molecules, the team thinks it is likely that their continued research will identify additional potent hair growth activators. Make sure to read the UC Irvine report of these findings.

Interestingly, Dr. Plikus says that this Nature publication is the result of nearly 10 years of research by an international team of scientists. The most encouraging quote of all from Dr. Plikus:

“It will grow like you remember it when you were 18. It would not grow like thickened, wiry armpit hair. This burst of molecules is shown to hair follicles on a scalp, and they’re like, ‘Oh, OK. Time to grow!'”

Update: In an interview with DermWire, Dr. Plikus says that the osteopontin-based compound highlighted in the Nature publication is designated as AMP-203 at Amplifica.

A Note on Osteopontin and Hair Growth

Note that I previously covered osteopontin in a number of my posts on Follicum, a company which disbanded in 2021 but came back in 2023 under new ownership. Their use of an osteopontin based peptide was slightly different from what Amplifica will be doing via osteopontin (plus other molecule) injections.

Follicum’s Phase 2 clinical trials resulted in a hair growth increase of 6.6 hairs/cm2, which was deemed insufficient to continue with Phase 3 trials at the time. Hopefully, the company’s new owners will have a change of heart.

Update: March 27, 2023

An interesting new UCI article covering the work of their hair scientists Maksim Plikus and Natasha Mesinkovska. Per Dr. Plikus:

“Most likely, SCUBE3 would be microinjected less than a millimeter beneath a person’s skin, a “fairly painless” process that would have to be repeated periodically to maintain hair growth”.

Human trials on Amplifica’s lead compound (likely not SCUBE3, which was my original assumption) are expected to begin later in 2023.

New Agreements with Ingenza and University of California

January 26, 2023 — Amplifica signed an exclusive licensing agreement with “The Regents of the University of California” for a proprietary pipeline hair growth molecule (SCUBE 3) that has been in the news a lot lately. Key quote:

“This early-stage compound (SCUBE3) will now be referenced as AMP-601 and is currently undergoing pre-clinical testing at Amplifica.”

January 20, 2023 — Amplifica to collaborate with UK-based Ingenza in order to advance novel alopecia treatments involving the former’s signaling molecules and proteins.

November 14, 2022 — Make sure to watch the below interesting recent video presentation by Dr. Plikus:

October 24, 2022

Amplifica

I previously mentioned new hair loss company Amplica in my post about Dr. Maksim Plikus’s research on the Scube3 molecule for hair growth. He partnered with Dr. William Rassman to create Amplifica. The latter announced his involvement via a Reddit comment in July 2022.

Amplifica Signaling Molecule
Amplifica announcement by Dr. Rassman on Reddit.

Earlier today, it was announced that Amplifica just completed a $11.8 million Series A Financing round. These funds will enable clinical development of the company’s lead products to treat androgenic alopecia.

These lead products are listed as “AMP-303” and “AMP-506”. The press release states that they expect to initiate first clinical trials in fiscal year 2023.

Amplifica
Amplifica.

Amplifica, Dr. Maksim Plikus and Hairy Moles

Note that Amplifica was first mentioned in a 2020 news article in regards to the new company’s interesting work in relation to hairy moles. At the time, a team led by Dr. Plikus discovered that molecules from moles that grow excessive hair can induce follicle growth when administered anywhere on the skin.

Make sure to also read my past posts on Dr. Plikus and his many areas of hair loss research breakthroughs. His team is based at the University of California, Irvine (UCI).

CK Regeon Releases its PTD-DBM Hair Booster

CK Regeon HairRegeon and Heribon.
CK Regeon HAIRREGEON and HERIBON.

Update: August 6, 2026

CK Regeon Releases HAIRREGEON (PTD-DBM Hair Booster) and HERIBON

Four years after I wrote this post (and almost 9 years after I covered the original research on the targeting of CXXC5 by PTD-DBM), CK Regeon (South Korea) finally released two brands of its products in July 2026.

One is a set of four topical products and the other is a PTD-DBM booster vial. I will add these to my growing list of new hair loss cosmeceuticals. Companies are increasingly using this route to bring new hair growth products to market fast, without going through long-lasting and expensive clinical trials.

  1. HERIBON. This line consists of four products that you apply to the scalp, including shampoo. Every HERIBON product features the WNTON Formula (a combination of KY19382 and hesperidin). I covered the KY19382 molecule when I first wrote this post in 2022 (scroll till the bottom).
  2. HAIRREGEON. The have a detailed blog post on their new site about the HAIRREGEON PTD-DBM Hair Booster. They say that:

“PTD-DBM helps restore healthy WNT signaling, which in turn supports a more optimized scalp environment and healthier hair growth conditions.”

August 26, 2022

In 2017, I covered the development of a new biochemical peptide material called PTD-DDM that would grow hair. The peptide targets the CXXC5 gene, resulting in activation of the Wnt/β-catenin pathway. This is turn leads to accelerated hair regrowth.

The South Korean team that conducted this research was led by Dr. Kang-Yell Choi, who even has a wikipedia entry. I previously also covered Dr. Choi in my post on valproic acid and hair growth.

CK Regeon

To bring this hair growth peptide (KY19382) to market, Dr. Choi started a company named CK Biotech that I mentioned in my original post. However, in 2021, it was renamed to CK Regeon.

Recently, I heard again about this company due its presentation at a June 30, 2022 South Korean symposium on the development of innovative new drugs for hair loss. This conference was led by Epibiotech and Yonsei University. On a side note, Inventage Lab also presented at this conference, indicating that finasteride injections are still on track.

CK Regeon
CK Regeon. Dr. Kang-Yell Choi’s new company targeting CXXX5 inhibition in order to restore Wnt/beta-catenin signaling.

Make sure to read CK Regeon’s regular press releases. On Linkedin, the company currently has 8 employees. On the company’s Twitter page, they keep sharing an updated infographic on the benefits of Wnt pathway activation. The latest heading:

“WNT Pathway restoration, a therapeutic target for tissue regeneration, diabetic wound healing, hair growth, non-alcoholic steatohepatitis (NASH), obesity and diabetes.”

On the company’s target diseases page and pipeline page, they include the above conditions as well as “countering short stature” and treating Alzheimer’s disease.

While I doubt that CK Regeon can cover all these bases, it is not surprising that the Wnt/Beta-Catenin signaling pathway is so crucial to human health.

Blocking CXXC5 and Improved Wnt/Beta-Catenin Signaling

Previously, we got excited about the potential of Samumed in curing hair loss by activating the Wnt pathway. Unfortunately, this company did not pan out after years of favorable publicity.

Another company named Frequency Therapeutics is trying to regrow inner ear hair cells via stimulating the Wnt signaling pathway. Fractional lasers and wounding also work on the same pathway, leading to a regrowth of scalp hair in some who are lucky.

CK Regeon’s overall technology entails blocking the CXXC5-Dishevelled (Dvl) protein-protein interaction (PPI). This is accomplished via the creation of new small molecules or peptides. This inhibition of CXXC5 results in restored Wnt/beta-catenin signaling and hair regrowth.

Note that CXXC5 is overexpressed in men with androgenetic alopecia (aka male pattern baldness). CXXC5 is a negative feedback regulator of the Wnt/beta-catenin pathway.