Category Archives: Minoxidil

Follica Pivotal Trial in 2019, FDA Filing in 2020.

Update: November 25, 2019 — A few days ago, “Toccata” emailed me a pdf document in which one small part mentioned that Follica was going to use Minoxidil as the compound after the microneedling.

Apparently, this document was also posted on several hair loss forums. However, no-one initially saw the page 46 small Minoxidil part except “Toccata” as far as I could tell. The new HLT thread on last week’s Follica news is already 10 pages deep. At this point, it seems like a few people have realized what was missed before and the pdf has been repasted several times.

I did not want to share this document right away. On Twitter, I first asked several members of the Follica team to contact me as I wanted permission to share the cartridge, dropper and new patient hair growth photos. In the past, several Follica staff members have responded to my requests and questions.

However, I got no response from anyone this time around despite two attempts on November 21 and 22. I did not mention anything about Minoxidil to them, so there must be another reason for the secrecy.

Follica Might Start off with Minoxidil :-(

I have now found the same document available online here. On page 46, it states: “Proprietary Minoxidil cartridges for use with smart dropper”. Crazy to see this after years of speculation.

For many years, most of us have assumed that Follica would use a compound that would at the very least be Minoxidil PLUS something else. Many people assumed that the second compound would be based on valproic acid, since Follica even has a patent in that area. So this news is a disappointment.

However, two important points to note:

  1. The above linked conference call pdf was published around three years ago and is old news. Moreover, things may change further before the end of 2020.
  2. It will be much easier to get initial US FDA approval for a microneedling based treatment that only involves the addition of Minoxidil. After all, topical Minoxidil has been approved as a hair loss treatment for decades. Some people even take the more dangerous oral Minoxidil to treat their hair loss.

Correct microneedling and wounding in combination with Minoxidil seems to give excellent results (e.g., see Rachita Dhurat and her India microneedling work). Most people who are experimenting with at-home microneedling are not doing it correctly. Hopefully, Follica’s micro-needling device in the hands of a professional will be much superior.

Even more hopefully, Follica will add other compounds into the mix down the road. Perhaps even something like wounding plus mesotherapy with Dutasteride.


November 21 2019: New Follica update via Puretech’s latest November 2019 presentation. (h/t “Toccata”).

Follica FDA Filing in 2020

They seem to be calling the product FOL-004. Previously they have used FOL-001, FOL-002 and FOL-003 in various clinical studies. The final name is supposed to be the acronym “RAIN”Note: The unrelated company Follicum labels its hair loss product as FOL-005!

Puretech has now raised its stake in Follica to 78 percent, indicating major optimism.

On page 32 of the presentation, it says that:

  • “Interim clinical readout of optimization study in AGA” was completed in 2019. Checkmark next to it on the left stands for completion.
  • In 2020, the company plans to get “Topline results from pivotal study in AGA” and also go through with FDA filing. Assuming data are supportive.

On page 40, they have a crown hair growth before and after photo. Pretty decent results in my opinion. It says the after photo is 85 days post the “screening” before photo. Not sure how many treatments were required over those 85 days.

The still use the phrase “newly created hair follicles”. Created via the wounding and microneedling procedure using Follica’s proprietary new device.

Apparently, the procedure will just take 5 minutes. Fingers crossed, maybe we will finally get this much touted product to market by the end of 2020.

The below post was published on May 12, 2019. See bottom of page for possible Follica Trial recruitment information.

Puretch Pipeline

Follica Clinical Trial Schedule

A few weeks ago, PureTech released its 2018 annual report. On page 31, you can find the summary for Follica. PureTech owned 62.3 percent of Follica at the end of 2018. Follica also updated its site recently as noted by one of this blog’s astute readers last month.

In the above linked PureTech report, the Follica page mentions that the company will start its “pivotal study” in 2019. They have already conducted three clinical trials in the past.

Per one definition, Pivotal study means Phase 3. Per other definitions that I have read, it means Phase 2b. Either way, we are making major progress. Considering that Follica’s methodology involves wounding and then use of existing drug compounds on the scalp, perhaps they can get away with a faster approval process.

I have covered Follica numerous times on this blog, only to be disappointed at its speed of progress each time. However, I have some interesting news to share about the company that I will split between two posts.

Recruiting Volunteers

While going through their new website in more detail, I noticed that one of their clinical advisers was a Dr. Jeffrey Dover. His was the only name that I did not recognize in the list. A little bit of research, and I found that Mr. Dover works at SkinCare Physicians.

I then went to SkinCare Physicians’ Twitter feed, and lo and behold, the below Tweet from February 14 says it all. I have no idea if this recruitment period is over, but please only call them if you are certain that you fulfill all the requirements, including travel to Chestnut Hill, MA). And do not call them just to ask general questions!

Update: Had to remove the embedded Tweet after a request from one of the company’s representatives. She emailed me and said that they were bombarded with a huge number of calls, with many volunteers not fully realizing the very specific travel requirements. A number of callers even pleaded to get in despite living in different countries! And of course many called just to ask general hair loss questions despite my explicit warning above :-(

How Does Minoxidil Work to Grow Hair?

How does Minoxidil work in growing hair? The below was originally written in 2014. It has now been updated with newer studies discussing Minoxidil’s mechanism of action in stimulating hair growth.

Minoxidil Chemical Structure

Minoxidil (brand name Rogaine) is known to be one of only two medications officially approved for hair loss treatment (the other being Finasteride).

Minoxidil was first approved by the US FDA to treat hair loss in men in 1988. In 1991 the product was also made available for women with hair loss. Make sure to read my post on whether Minoxidil can grow a beard.

Also see some before and after results of Minoxidil and Finasteride.

How does Minoxidil Work?

Scientists do not know the exact mechanism via which Minoxidil® has a positive effect on hair growth. However, there are a number of proven mechanisms of action that suggests how Minoxidil works to stimulate hair growth.

The original use of Minoxidil was as an oral medication for high blood pressure. See my post on oral Minoxidil. The side effect of hypertrichosis (excessive body hair) led to its becoming a popular treatment option for hair loss.

To date, the main hypothesis about how does Minoxidil work relates to its vasodilatory, potassium channel opening and increased blood flow effects. There are also other theories about how Minoxidil helps grow scalp hair, and further below I have outlined all of the main ones.

It should be noted that Minoxidil, besides prolonging the growth phase of the hair cycle, has also been shows to increase the diameter of existing hair follicles. According to a study from 1988, seven subjects who received a 5 percent dose of minoxidil had a mean hair shaft diameter of 0.029 mm before treatment. This hair width then increased to 0.043 mm at 12 weeks.

History of Minoxidil

  • In 1979, Minoxidil was first approved by the US FDA. However, its usage was as an oral blood pressure medication (brand name Loniten) rather than as a hair loss treatment.
  • In 1988, the FDA first approved Minoxidil as a hair loss treatment. This was via a topical 2% solution formulation under the brand name Rogaine, owned by Upjohn Company. However, Rogaine was only available via prescription, and it was only meant for use by men.
  • In 1991, the FDA approved Minoxidil as a hair loss treatment for women, but by prescription only.
  • In 1992, Rogaine launched a 2% Minoxidil topical solution for women, only available via a prescription.
  • In 1996, the FDA approved the over-the-counter sale of 2% topical Minoxidil and also allowed the production of generic formulations of Minoxidil. Upjohn subsequently drastically cut the price of Rogaine in order to compete in the now much more competitive market.
  • In 1997, Upjohn released a 5 percent topical solution formulation of Rogaine. It was only available by prescription and for men only.
  • In 1998, the FDA approved a 5 percent formulation of Minoxidil for over-the-counter sale to men.
  • In 2006, Rogaine launched a 5% Minoxidil foam product for the first time. It was immediately available for over-the-counter purchase, but only recommended for men.
  • In 2011, men’s Rogaine foam was made available in unscented format.
  • In 2014, Women’s Rogaine 5% Minoxidil foam was approved by the FDA, but with a once a day treatment recommendation. Men are always supposed to use Minoxidil twice a day.

Mechanism of Action References and Studies:

  • In 1997, researchers found that Minoxidil increased prostaglandin synthesis (more specifically, prostaglandin synthase-1, abbreviated as PGHS-1) in cultured dermal papilla cells. In more recent years, the issue of prostaglandins and hair loss has garnered a great deal of attention and you can search for “PGE2” on this blog to learn more.
  • A French study from 1998 is among many that has found that Minoxidil upregulates growth factors, in particular vascular endothelial growth factor (VEGF).
  •  A 2001 study found that the positive effect of Minoxidil on hair is mediated by adenosine.
  • An excellent article from 2008 on hair loss medical treatments by Dr. Nicole Rogers and Dr. Marc Avram that discusses Minoxidil in detail. They mention that one of the main effects of Minoxidil is angiogenesis and increased blood flow in the area of application. They also discuss the enhanced cell proliferation and DNA synthesis effects on Minoxidil that might be benefiting hair growth.
  • In 2011, South Korean researchers found that Minoxidil activated the β-catenin pathway in human dermal papilla cells and therefore extended the anagen (growth) phase of the hair cycle.
  • In April 2014, Taiwanese researchers came up with yet another reason as to why Minoxidil works, concluding that it may suppress androgen receptor-related functions. i.e., the drug has anti-androgenic properties. Their conclusion is especially interesting:

The current findings provide evidence that minoxidil could be used to treat both cancer and age-related disease, and open a new avenue for applications of minoxidil in treating androgen-AR pathway-related diseases.

Minoxidil enhances hair keratinocyte proliferation and activates hDP cells to induce growth factors. IGF-1 is among these growth factors, and has been shown to exhibit a potent hair elongation effect.

  • In June 2017, US researchers published a new study that provided significant insights into how Minoxidil foam worked via upregulating and downregulating various genes. Interestingly, vertex and frontal scalp of patients showed a generally similar response to Minoxidil. Many online reports suggest that minoxidil might work better in the crown than in the front, but perhaps that is not true based on these findings.
  • In February 2018, South Korean scientists discovered that Minoxidil promotes hair growth through the stimulation of growth factor release from adipose-derived stem cells. This growth factor secretion may enhance hair growth by promoting dermal papilla cell proliferation.

Minoxidil Side Effects

In general, topical Minoxidil is well tolerated in most people at the typical 5% dosage. Most people even tolerate higher concentration levels of the drug. However, some people will get side effects.

The most common entail adverse skin reactions such as burning, itching, redness and stinging in the areas of application. Another common complaint is an increase in body hair growth after taking Minoxidil, especially in the forehead, eyebrow and beard regions.

In rare instances, people complain about dizziness or breathing difficulties after taking Minoxidil. Allergic reactions, including rashes, are also possible in some cases. Please see a doctor immediately if you get such serious side effects. Also make sure to stop using this medication right away.

Some people will shed a lot of hair after changing their Minoxidil® dosage. For those who quit Minoxidil entirely, a major shed of scalp hair is almost always guaranteed. Sometimes this can take weeks or even months after drug use cessation. In many instances, sheds are temporary and just the regular part of the hair cycle.

Toxicity in Cats

If you own pets, note that Minoxidil® is very poisonous to some animals, especially cats. If your cat is exposed to Minoxidil via a spill or accident, some side effects to look out for include:

  • Fatigue and lethargy.
  • Changes in heart rate due to cardiac damage.
  • Dehydration.
  • A drop blood pressure (hypotension).
  • Coughing.
  • Changes in appetite.

Prompt action and treatment by a veterinarian will prevent your cat from dying. If the medication was applied topically, make sure to wash the cat’s paws and fur promptly and thoroughly.