Hope Medicine Trials and Fundraising

Hope Medicine LogoRead the bottom half of this post for a history of Hope Medicine and Bayer’s HMI-115. This treatment targets the prolactin (PRL) receptor to cure hair loss. Hope Medicine raised $56 million in funding in 2021. Their pipeline page is worth monitoring.

The initial reason for all this excitement was due to the spectacular long-lasting hair growth results seen in stump-tailed macaque monkeys. Per the clinical trial participant I mention further below, these monkeys are still being monitored and have not lost their hair over four years after prolactin receptor antibody treatment.

Prolactin Hair Growth
Hope Medicine and Bayer prolactin receptor antibody hair growth. Before and after in stump-tail macaque monkeys. The hair growth remained even several years post cessation of treatment.

Update: November 16, 2022 —  A November 2, 2022 detailed Reddit update from a trial participant (dose 1 and dose 2) in Australia is required reading. This 37-year old guy had his first two doses (in one month) of the prolactin blocker via injection. He, along with his female partner (age 46) will get treatment every two weeks for six months. So a total of 12 doses, all at Sinclair Dermatology in Melbourne. Note that while these are Phase 1 trials in Australia, the same HMI-115 product is scheduled to undergo Phase 2 clinical trials in the US anytime soon.

This Redddit user moeman32 seems completely legitimate and has been on Reddit for over ten years. He has also posted about Australia many times in the past. We all owe him major respect. He will do follow-up posts every two weeks. Note that all 20 patients in this Phase 1 safety trial are getting the actual drug (i.e., no placebo needed to test efficacy this time around).

“The vortex existing hair has filled out much thicker and quicker. The frontal scalp is now growing dormant hair. The hairline has definitely moved 15mm forward and the hair is a few cm long (havent had a haircut since before the trial). All in all, it is making a visible difference to my hairline.”

Update: June 22, 2022 — Hope Medicine’s website is now working. Thanks to reader “Pinotq” for letting us know. See their research section and pipeline pages.

Update: April 12, 2022 — For some reason, Australian Phase 1 trials for Hope Medicine’s HMI-115 are starting today. They will involve 20 participants and are expected to be completed in July 2023. The trials will be led by the renowned hair loss expert Dr. Rodney Sinclair. Also see his current clinical trials recruiting page hair section.

Update: April 14, 2022 — Lots of excitement on Reddit.

Meanwhile, US Phase 2 trials should start at any moment now (read further below). This difference in trial progression by country is very strange. Perhaps is has to do with some stricter Australian government requirements.

Update: January 26, 2022

Hope Medicine HMI-115 Phase 2 Trials

Hope Medicine just received FDA approval to commence Phase 2 clinical trials in the US for its HMI-115 product to treat androgenetic alopecia. HMI-115 is a human monoclonal antibody drug that targets the PRL receptor for the treatment of male and female pattern hair loss. Last year, the US FDA also approved Phase 2 trials of the same drug to treat endometriosis.

The Phase II clinical trial of HMI-115 for the treatment of androgenetic alopecia:

“Will be an international multi-center, randomized, double-blind, placebo-controlled study. It will be carried out in the United States, Australia and other countries.”

Update: November 28, 2021

New CEO Henri Doods Interview

A reader sent me the below screenshot of Hope Medicine CEO Henri Doods’ Chinese magazine interview that I mentioned earlier. If anyone can translate into English, please post in the comments. Click on the image to expand.

Hope Medicine Doods Interview
Hope Medicine CEO interview.

Update: September 20, 2021

Hope Medicine CEO Henri Doods
Hope Medicine CEO Henri Doods.

Reader “Karl” just notified us that there is a brand new cover page interview of Hope Medicine’s CEO Dr. Henri Doods in a Chinese magazine “tradetree.cn”. If anyone can gain access to it (see here) and translate into English, please try. Not worth purchasing as yet in my opinion.

Per Karl, Phase 2 clinical trials for hair loss product HMI-115 are planned for Q4 2021 (but no proof anywhere else). This matches what we expected per the prior updates that I discussed in May (see further below). Note that HMI-115 is the same as Bayer’s prolactin receptor antibody. Hope Medicine has the rights to the development of this product.

May 9, 2021

Hope Medicine (China) Raises $56 Million

Until now, Kintor Pharmaceutical (China) was the main reason for recent excitement. However, this weekend, the participants on this site’s hair loss chat are discussing Hope Medicine. Out of the blue, this startup company received $56 million in a Series B round of financing. Investment firms Qiming Venture Partners and Grand Flight Investment led the way.

Other investors include: HighLight Capital; Sinovation Ventures (a venture capital firm led by former Google China head Kai-Fu Lee); and Trustbridge. More here.

HMI-115 PRL Receptor Targeting: Bayer License

“Previously, HopeMed signed an exclusive license agreement with Bayer AG on the development and commercialization of a human antibody (HMI-115) targeting the prolactin (PRL) receptor for the treatment of male and female pattern hair loss. At present, HMI-115 has completed phase I clinical trials in the European Union, with positive safety results. The global multi-center phase II clinical trials for androgenic alopecia and will soon be launched.

Ruiping Xiao
Dr. Rui-Ping Xiao

Note that I first covered Hope Medicine in my 2019 post on its partnership with Bayer in regards to the prolactin receptor. The company was founded by Dr. Rui-Ping Xiao, the dean of the College of Future Technology of Peking University. Apparently, she is also an associate editor of the New England Journal of Medicine. Update: See this page for much more on Dr. Xiao Ruiping.

The most unusual part of this story is that Hope Medicine’s official website (hopemedinc.com) has not worked for weeks. I have e-mailed several of their employees, and will update this post if I get any response.

Oral Minoxidil to Treat Hair Loss

Since I first wrote this post a few years ago, there have been many new favorable oral Minoxidil and hair growth related studies. The news media has also widely covered this subject since mid-2022. I will keep republishing this post every time there are a few new updates to discuss on top.

Please consult your doctor or dermatologist before taking oral or sublingual Minoxidil. One of the studies I mention discusses how compounded low-dose oral Minoxidil (LDOM) is often of a much higher dosage due to compounding error. Taking this drug is no joke and it must be used under medical supervision.

Latest Oral Minoxidil and Hair Growth News Updates and Studies

Update: November 21, 2022 — Interesting (slightly modified) quote from Dr. Rodney Sinclair in a new article on oral Minoxidil for hair growth. Makes me think that “Quentin” who pushed me into discussing amino acids (and cysteine in particular) was correct.

“Minoxidil prolongs anagen duration (increasing hair length), increases fiber diameter, reduces breakage and reverses hair miniaturization. It does this by increasing the uptake of the amino acid cysteine into the hair bulb outer root sheath. Transport of cysteine into hair cortex keratinocytes in the emerging anagen fiber is the final step in hair keratinization and the rate-limiting step in hair growth.”

Update: November 9, 2022 — A highly encouraging anecdotal report from a long-time 74-year old reader (and hospital pharmacy consultant) who I fully trust. He has never seen a drug as effective as low-dose oral Minoxidil for hair growth, and he has tried them all. His past hair transplant surgeon who I know well also verified his legitimacy.

Update: October 13, 2022 — In a recent article from the prestigious Cleveland Clinic, Dr. Wilma Bergfeld is full of praise for oral Minoxidil. Key quote:

“It has really been the best drug we ever had for hair growth.”

Update: October 7, 2022 — How Australia is winning the hair loss battle. Dr. Rodney Sinclair is quoted as follows regarding low-dose oral Minoxidil:

“We’ve now treated 20,000 people with it. It’s been a game changer hair loss treatment. Minoxidil [as a pill] has pretty much 100 per cent success at stopping progression. Regrowth will be about 20 per cent of what they’ve lost.”

Really amazing if true. Dr. Sinclair’s patients are prescribed doses ranging from 1-5 milligrams of Minoxidil. This compares to 10-40 milligrams when used as a blood pressure treatment.

Update: August 25, 2022 — Yet another great video, with several impressive before and after photos. Courtesy of the well known hair transplant surgeon Dr. Nicole Rogers.

Update: August 18, 2022 — The New York Times just published an article on oral Minoxidil for hair loss. It describes the drug as an old medicine that grows new hair for pennies a day. It is becoming increasingly popular for off-label use in treating hair loss. Dr. Brett King makes an interesting point about their likely never being  expensive clinical trials for such a low-cost product.

Update: July 20, 2022 — A new study finds that serious adverse side effects with low-dose oral Minoxidil for hair loss were due to compounding errors. After pharmacological lab analysis of formulated capsules, it was found that all the patients with serious side effects were receiving much higher doses than prescribed. This was due to compounding mistakes. While the prescribed dose of oral minoxidil ranged between 0.5 and 1 mg, these patients were getting between 50 and 1000 mg per capsule. Please be careful if you ever go this route for your hair loss treatment.

Note that per the above article, doses of between 1.25 and 5 mg can be obtained by halving or quartering the marketed drug (Loniten®, Pfizer). The above issue is only with compounded LDOM of 1mg or lower. According to Dr. Robert Haber (US):

“I never recommend compounded minoxidil. Rather, I prescribe the 2.5mg tablet and have the patient cut them in half or quarters, depending on the dose.”

Update: March 4, 2022 — A new study (with Dr. Jerry Cooley as a co-author) concludes that oral minoxidil can be an effective treatment for androgenetic alopecia and telogen effluvium.

Update: January 5, 2022 — Coming full circle in the use of low-dose oral Minoxidil (LDOM) in the treatment of alopecia.

Sublingual versus Oral Minoxidil

Oral Minoxidil Generic 5 mg.
Oral Minoxidil 5 mg.

Yesterday, “Nik” on our Discord group mentioned how sublingual Minoxidil (3 mg/day) was superior to oral Minoxidil in growing hair amongst his friends. Make sure to read my past post on Minoxidil as a sublingual tablet.

He then linked to this 2020 report on 64 patients where the dose was only 0.45 mg/day. The author is Dr. Rodney Sinclair of Australia, who I cover in detail at the bottom of this post. I posted about this on Twitter, and Dr. Corralo and Dr. Bhoyrul responded with very interesting comments:

Sublingual vs Oral Minoxidil

Sublingual Minoxidil Sulfate

Upon further research, I also found this newer August 2021 report from Dr. Sinclair. It entails a Phase 1B clinical trial, which is very encouraging news. Detailed summary from October 2021 can be read here. The interest in oral Minoxidil for hair growth has really taken of during the past few years. Online anecdotes indicate superiority over topical Minoxidil, but I am not yet 100 percent certain.

“Almost 67% of patients who received the 4.05 mg dose experienced improvements in frontal and vertex hair density. In the 0.45 mg dose group, phototrichograms showed a mean increase in terminal hair count/cm2 of 4 for the frontal and 9 for the vertex scalp. Treatment with the 1.35 mg dose resulted in a mean increased terminal hair count/cm2 of 10 and 26. The 4.05 mg dose led to a mean increase terminal hair count/cm2 of 38 for the frontal and 88 for the vertex scalp.

According to Dr. Mirmirani’s succinct summary at the bottom of that page:

“The authors suggest that sublingual Minoxidil (SM) may have better bioavailability and fewer hemodynamic effects by avoiding first-pass liver metabolism. Will SM be a game changer? Although the data in this study are positive, it will take more to convince me that it is significantly better than oral Minoxidil (OM). Very few of my patients on low-dose OM for hair loss discontinue the medication due to side-effects. The other consideration is cost. OM it is an inexpensive, generic drug, that is covered by medical benefits.”

Other Newer Studies

Update: October 2021 — New study finds that low-dose oral minoxidil increases hair density and thickness.

Update: August 2021 — A review of low dose oral Minoxidil treatment for hair loss.

Update: February 2021 — Safety of low-dose oral minoxidil (LDOM) for hair loss in 1404 patients. Multicenter study. The most frequent adverse side effect was hypertrichosis.

Oral Minoxidil Hair Growth
Oral Minoxidil Hair Growth Before and After. Source: JAAD.

Since I first wrote this post on oral Minoxidil several years ago, a number of major new developments have occurred.

An October 2020 study of low-dose 1.25 mg nightly treatment with oral Minoxidil (Loniten) for three months concluded favorable increases in hair growth. More here. This is surprising, considering the low dose utilized relative to other studies. The hair loss patients included males and females of various ethnicities. Further treatment with 2.5 mg dosing was also analyzed.

In September 2020, a Thai study found good results for men taking oral Minox 5mg daily. In July 2020, a review of 16 studies encompassing 622 patients concluded that oral Minoxidil is an effective and well-tolerated hair loss treatment. However, more statistical data is still needed. Also see this June 2020 article that concludes low-dose 1.25 mg/day

In August 2019, Spanish researchers published positive findings on low-dose 5 mg per day oral Minoxidil. One of the results from this study can be seen in the above before and after hair growth photo. It was sent to me by Dr. Sergio Vañó.

Oral Minoxidil for Hair Loss

For many years, I have heard that oral Minoxidil results in even more hair growth compared to the topical version. This is true for both male and female pattern hair loss (often in combination with Spironolactone for women). However, I always assumed that the side effects from the oral medication would be much worse.

The health related side effects include blood pressure fluctuations, heart rate changes, and potential water retention. However, I was most concerned about the side effect of excess body hair growth from Minoxidil pills turning me into a werewolf. Note: Make sure to read my post on topical Minoxidil and beard growth.

Introduction

I have discussed Minoxidil (brand name Rogaine) many times on this blog in the past. It is one of only two drugs officially approved by the US FDA to treat male pattern hair loss. The other being Finasteride, which targets dihydrotestosterone (DHT) reduction.

Most men use 5% topical Minoxidil foam and apply it to their scalps twice per day. For those who get adverse reactions, dosage is sometimes reduced to once per day. Women tend to use the 2% topical formulation to regrow thinning hair. Until recently, very few people used oral Minoxidil to treat male androgenetic alopecia or female pattern hair loss.

Unbeknownst to many, Minoxidil was originally approved in 1979 as an oral medication (brand name “Loniten”) to treat hypertension (high blood pressure). It was only approved for treating hair loss in men in 1988 as a topical medication.

A women’s version was approved in 1991. To this day, it is not entirely clear as to how Minoxidil works in promoting hair growth, with a number of theories out there, implying the likely involvement of multiple mechanisms. These include agonistic affects on adenosine-triphosphate (ATP)-sensitive potassium channels; prostaglandin stimulation in the dermal papillae; and anti-androgenic properties.

Advantages over Topical

Among the advantages that oral Minoxidil has over topical Minoxidil include:

  • Once a day pill is easier to remember than twice a day topical application.
  • Less time consuming to just take a pill or tablet.
  • No mess to deal with on the scalp.
  • No side effects on the scalp such as itchiness, redness, irritation, greasiness, dry hair and so on.
  • No need to wash hair to get rid of the product.
  • No chance of the product getting into the eyes or dripping down forehead.
  • Generic oral Minoxidil pills work out to be cheaper than topical Minoxidil foam.

Low-Dose Oral Minoxidil for Hair Loss

Several years ago, I read a very lengthy and thoughtful comment by Thai hair transplant surgeon Dr. Damkerng Pathomvanich. He outlined why he prescribes oral Minoxidil to a select few of his patients   Low-dose oral Minoxidil (LDOM) for hair loss in select patients can be very effective. Update: In October 2020, Dr. Ratchathorn Panchaprateep from Thailand also released positive findings in relation to this drug.

According to Dr. Path (as well as per other physicians that had given him feedback), 5 mg per day was an ideal dosage that did not change patient blood pressure readings significantly. Some physicians even recommend trying 2.5 mg per day. In fact doses as low as 0.25 mg to 1.25 mg per day have results in hair growth in some patients.

However, some western publications and websites recommend a lower dosage (see links in some of the comments to this post). Image below shows generic 5 mg Minoxidil tablets from Thailand. Please do not try to buy this online as it can be dangerous.

Side effects are still possible at low doses. Dr. Pathomvanich does not prescribe oral Minoxidil to patients who have blood pressure, heart, liver or kidney problems.

Note that according to the official brochure for Loniten, maximum recommended dosage is listed as high as 100 mg per day, which seems crazy. Most patients taking the drug for hypertension do not cross 40 mg per day.

Side Effects

Another major recent news story regarding oral Minoxidil also comes from Spain in August 2019. Apparently, 17 infant children were mistakenly given oral Minoxidil instead of heartburn medication.

Update: December 2020 — Over a year after the medical error, families of some children are complaining that the body hair keeps growing. Also from Spain, a September 2020 study on low-dose oral Minoxidil and hypertrichosis.

Oral Minoxidil Hypertrichosis Body Hair Side Effect.
Oral Minoxidil Excessive Body Hair Increase Side Effect.

The children subsequently developed a condition called “werewolf syndrome” in which large parts of their bodies become covered in hair. This condition is also referred to as hypertrichosis.

Luckily, the body hair will disappear a few months after the children stop taking oral Minoxidil. Above photo is from the video of this shocking news story.

Dr. Sinclair Recommends Oral Minoxidil

I had forgotten about the above till today, when commentator “Billa” posted an interesting link to a new audio interview with Australian Dr. Rodney Sinclair. I have covered this well known hair expert a number of times on this blog in the past.

In this latest interview, one of the things that Dr. Sinclair states is that oral Minoxidil is much more effective than topical Minoxidil when it comes to hair growth. He reaches this conclusion based on some clinical trials that his clinic is currently undertaking. Make sure to also check out my post on Dr. Sinclair’s Hairy Pill.

While the article describing the above interview states that side effects from oral Rogaine were not significant, I did not hear that in the audio interview. I am guessing that this must be true or else they would stop conducting the trials.

Dr. Sinclair has also successfully tested oral Minoxidil and Spironolactone combination treatment in female pattern hair loss patients.

Update: Dr. Vikram Jayaprakash from Australia now also recommends oral Minoxidil for hair loss.

Note that oral Minoxidil is not currently FDA approved for treating hair loss. I do not intend to take the drug, mostly because I do not want to risk getting any more body hair.

Hair loss treatment and cure related news updates.