Oral JAK3 Inhibitor Granted for Alopecia Areata

Oral JAK3 Inhibitor Granted for Alopecia Areata

Pfizer Receives Breakthrough Therapy Designation from FDA for PF-06651600, an oral JAK3 Inhibitor, for the Treatment of Patients with Alopecia Areata

Phase II data accepted for late-breaker news session at 2018 EADV Congress

Pfizer Inc today announced its investigational oral Janus kinase 3 (JAK3) inhibitor PF-06651600 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body.1,2

The Breakthrough Therapy designation for alopecia areata was supported by positive results from a Phase 2 study, which will be presented during the late-breaking news session at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris on September 15, 2018.

Currently, there are no FDA-approved treatments for alopecia areata, which impacts millions of people worldwide and is often associated with profound psychological consequences.1,2

“We are encouraged by this Breakthrough Therapy designation as it underscores the potential of our JAK3 inhibitor to address a critical unmet need,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “We are continuing to work closely with the FDA on the development process with the goal of bringing this potential new treatment to patients living with alopecia areata as soon as possible.”

Breakthrough Therapy designation was initiated as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) signed in 2012.

As defined by the FDA, a Breakthrough Therapy is a drug intended to be used alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

If a drug is designated as a Breakthrough Therapy, the FDA will expedite the development and review of such drug.3

Pfizer is also working with the European Medicines Agency (EMA) on the clinical development program for PF-06651600.

About Alopecia Areata

Alopecia areata is an autoimmune disease, characterized by hair loss, often patchy, on the scalp, face, or body.1,2 People suffering from alopecia areata experience symptoms when immune cells attack healthy hair follicles, causing the hair to fall out, often starting with smooth, round patches.1,2 The mean age of onset is between 25 and 35, but it can also impact children and adolescents and is seen in both sexes and all ethnicities.1,2 More than half of the patients with alopecia areata experience poor health-related quality of life and, as a result, the condition may lead to serious psychological consequences, including high levels of depression and anxiety.1

About PF-06651600 and Pfizer’s Kinase Inhibitor Leadership

The JAK pathways are believed to play an important role in inflammatory processes as they are involved in signaling for over 50 cytokines and growth factors, many of which drive immune-mediated conditions.4 JAK inhibition offers the potential for new advanced treatment options for these conditions through unique and targeted selectivity.5

“Pfizer strives to continue moving the JAK science forward with development of multiple JAKis with unique selectivity profiles that are being evaluated in clinical trials. These inhibitors have the potential of meeting significant unmet needs in multiple inflammatory conditions,” said Michael Vincent, Chief Scientific Officer, Pfizer Inflammation & Immunology.

PF-06651600 is an oral small molecule that selectively inhibits Janus kinase (JAK) 3.5 PF-06651600 is also under investigation for the treatment of rheumatoid arthritis, Crohn’s disease, and ulcerative colitis.

Pfizer has established a leading kinase research capability with multiple unique kinase inhibitor therapies in development. As a pioneer in JAK science, the Company is continuing to advance several investigational programs for molecules with novel selectivity profiles, which, if approved, could potentially deliver transformative therapies for patients. In addition to PF-06651600, Pfizer has the following kinase inhibitors in trials across multiple indications:

PF-04965842: A selective JAK1 inhibitor in Phase 3 clinical trials for the treatment of atopic dermatitis(AD)6; PF-04965842 received Breakthrough Therapy designation from the FDA for the treatment of patients with moderate-to-severe AD
PF-06700841: A tyrosine kinase 2(TYK2)/JAK1 inhibitor under investigation for the treatment of psoriasis, Crohn’s disease, ulcerative colitis and alopecia areata
PF-06650833: An interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitor under investigation for the treatment of rheumatoid arthritis
PF-06826647: A TYK2 inhibitor under investigation for the treatment of psoriasis and inflammatory bowel disease (IBD)

Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer healthcare products.

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.

For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at In addition, to learn more, please visit us on and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at

DISCLOSURE NOTICE: The information contained in this release is as of September 5, 2018. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

Oral JAK3 Inhibitor Granted for Alopecia Areata


Hair Loss and Balding in Women

Nolopecia Balding and Prostate Cancer

Balding and Prostate Cancer: Lilac Corp reviews a study and recommends Nolopecia, a natural treatment for hair loss

All natural hair loss supplement sold by Lilac Corp

Lilac Corp reviews a study that tested a possible link between early hair loss and prostate cancer.

Nolopecia, targets the latent viruses in the body. This helps the body maintain a normal level of the 5alpha-R, DHT, and AR proteins. A normal level of these proteins stimulates hair growth.”

A study showed that men with very early onset balding are more likely to develop aggressive prostate cancer, and at a younger age [1]. Some prostate cancers are more dangerous than others. Prostate cancer and androgenic alopecia, also called male pattern baldness, are both dependent on androgen hormones.

The study surveyed 1,941 men and found that men balding at age 20 years had a 50% higher chance of developing aggressive prostate cancer.

Also, these men were diagnosed with cancer an average of 16 months earlier than non-balding men.

Men balding at age 40 years and older, or non-balding men did not have the increased risk. Research like this is important because it helps to identify groups of men with a higher risk for aggressive cancer.

Men who are at a higher risk can perform regular screening tests for prostate cancer and should be followed up closely with their doctor.

For men (and women), who suffer from hair loss and balding, Lilac Corp recommends the natural treatment Nolopecia. Lilac Corp is the company that invented the highly effective and unique antiviral natural treatments Gene-Eden-VIR and Novirin.

The new treatment, called Nolopecia, targets the latent viruses in the body. This helps the body maintain a normal level of the 5alpha-R, DHT, and AR proteins. A normal level of these proteins stimulates hair growth.

There are many treatments for hair loss on the market.

However, only Nolopecia targets the latent viruses that cause the increase in 5alpha-R, DHT, and AR observed in people with hair loss and balding.

About Lilac Corp:

Lilac Corp specializes in the development of biology-based patent protected natural treatments. Currently, Lilac Corp is selling four products: Gene-Eden-VIR, Novirin, Nolopecia, and Noacnin. Lilac Corp ships its products to more than 100 countries around the world.

What makes Lilac Corp special is that all its products are tested in clinical studies that follow FDA guidelines. To ensure transparency, the results of the clinical studies are published in leading scientific journals. Lilac Corp also offers a 90-day money back guarantee.

[1] Papa, N., MacInnis, R., English, D., Bolton, D., Davis, I., & Lawrentschuk, N. et al. (2017). Early-onset baldness and the risk of aggressive prostate cancer: findings from a case-control study. Cancer Causes & Control, 29(1), 93-102. doi: 10.1007/s10552-017-0981-0


Improved Minoxidil Formulation Safe, Effective for Androgenetic Alopecia

hair loss supplements

Pediatric Alopecia Areata Severity Linked to Serum Vitamin D

Pediatric Alopecia Areata Severity Linked to Serum Vitamin D

For pediatric patients with alopecia areata, vitamin D is negatively correlated with disease severity, number of patches, and disease duration, according to a study published online in the Journal of Cosmetic Dermatology.

Mehmet Unal, MD, and Gulsum Gonulalan, MD, from the Konya Numune Hospital in Turkey, examined vitamin D status in 20 pediatric patients with alopecia areata and 34 pediatric healthy controls. The authors assessed the correlation between vitamin D status and disease severity, number of patches, and disease duration.

The researchers found that the mean serum 25-hydroxyvitamin D concentration was 15.47±7.66 and 11.09±10.53 ng/mL in patients and controls, respectively; no statistically significant difference was seen between the groups (P =.084).

Significant, negative correlations were seen for vitamin D concentration with the Severity of Alopecia Tool score (P <.001; r, -0.831), number of patches (P <.001; r, -0.989), and disease duration (P <.001 and r, -0.997).

“Vitamin D deficiency is not the only etiologic factor in alopecia areata pathogenesis, but in the presence of other etiological factors, this deficiency can aggravate alopecia areata severity, and thus, vitamin D supplementation may be beneficial in treatment of pediatric alopecia areata,” the authors write.


alopecia research

Alopecia Treatment Market Significant Profits Estimated to be Generated by 2022

Alopecia (Hair Loss)Treatment Market Significant Profits Estimated to be Generated by 2022

Alopecia is a term used to describe excessive hair damage under certain medical conditions or dietary issues. Sedentary lifestyle, and unhealthy diets is leading to loss of hair among masses.

Furthermore, ageing and hormonal imbalance, increasing chronic disease like arthritis, cancer, hypertension, depression also leads to hair loss especially among middle aged population.

According to American Hair Loss Association, androgenetic alopecia accounts for over 95% of hair loss in men.  Over 800 thousand patients are seeking some kind of treatment for hair loss worldwide.

A sample of this report is available upon request @

For the treatment of alopecia, U.S. FDA proved two drugs – Minoxidil, to treat hypertension and finasteride (Propecia) to treat benign prostate hyperplasia (BPH). American Hair Loss Association recommends the use of minoxidil in patients who have not responded to finasteride treatment. Prevalence rate of alopecia is high among working age population.

Propecia hair loss

Treatment seeking rate for alopecial is more prevalent in developed regions as compared to that in developing regions, however, over the past few years, demand for alopecia treatment has increased dramatically in developing regions such as China and India owing to increase in healthcare expenditure and improved healthcare infrastructure facilities. In China, 6 percent females and 21 percent of males suffer from hormone driven hair loss.

Changing lifestyle along with increase in stress level among working class population is expected to boost the demand for treatment of hair loss globally.

Furthermore, rise in geriatrics population along with high demand for surgical hair transplant is expected to drive the alopecia treatment market. Increasing consumer disposable incomes and health awareness, emphasis to look good, and technological advancement in hair treatment medical devices are some other key drivers for this market.

Since accessibility for scalp treatment is easily accessible and available, the demand for alopecia treatment has increased.

Though the market is expected to witness healthy growth during the forecast period, high cost of the medications and possible side effects/allergic reactions are acting as key barrier for alopecia market.

Alopecia Treatment Market is broadly classified on the basis of the following segments –

Alopecia Treatment Market by Product:

Vitamins and Supplements
Shampoos and Conditioners
Others (Serums, gels and oils)

Alopecia Treatment Market by Gender:


Alopecia Treatment Market by End User:

Homecare Settings
Dermatology Clinics
Others (Salons)

The alopecia treatment market has grown substantially at a healthy CAGR due to changing lifestyle and greater emphasis on outward appearance to look good. With rapid technological advancement and innovation, alopecia treatment market is expected to grow globally.

North America is the largest market for alopecia treatment while Asia Pacific is expected to be the fastest growing market during the forecast period.

The alopecia treatment market is expected to register a significant CAGR during the forecast period. Depending on geographic regions, alopecia treatment is segmented into seven key regions: North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America, followed by Europe, is expected to dominate the alopecia treatment market throughout the forecast period.

Asia Pacific excluding Japan is poised to witness fastest growth owing to outburst of middle aged population in the region. Also, the region is witnessing healthy growth in terms of GDP, which in turn is expected to propel growth at healthy digits. Middle East & Africa and Latin America are expected to sluggish growth during the forecast period.

Some of the key market players for alopecia treatment market are Cipla, Viviscal, Dr. Reddy’s Laboratories Ltd., Regaine, Merck & Co., Inc, Ranbaxy Laboratories Ltd, Phyto – Alès Groupe, Kirkland Signature, Vitabiotics, Nanogen, Alpecin – Dr. Kurt Wolff GmbH & Co. KG, Rogaine – Johnson and Johnson.