Category Archives: Cosmo Pharmaceuticals

Breezula, Cosmo Pharmaceuticals

Breezula Phase 3 Clinical Trials in 50 Locations

28 Comments

There are 50 locations across 4 countries (US, Georgia, Germany and Poland) for Breezula Phase 3 Trials. If you are in the US, please search for your state (or nearby state) in both the SCALP1 and SCALP2 breakouts on this page.

Breezula Phase 3 Clinical Trials.
Breezula Phase 3 Clinical Trials. Source: Cosmo Pharmaceuticals.

Breezula Phase 3 Clinical Trials

In my recent post about Cosmo Pharmaceuticals’ update on Breezula’s Phase 3 clinical trials, we learnt that the enrollment is still less than 60% compelete. This despite the fact that these trials started in June 2023. As of March 2024:

  1. 348 out of a planned 726 patients have been recruited in study CB-03-01/37.
  2. 507 out of a planned 726 patients have been recruited in study CB-03-01/38.

One reason for this slow pace of recruitment is that the inclusion and exclusion criteria are quite stringent.

  • While both the clinical trial page links below say that only men above 18 are allowed, our own “Yoda” tried to get in and was told that men abve 55 are also not allowed.
  • Only men who have mild to moderate androgenetic alopecia (AGA) in the temple and vertex regions (ranging from III to V on the Norwood-Hamilton Scale) are eligible. They must also have ongoing hair loss.
  • You have to revisit the center several times over 6 months, and apply the topical clascoterone solution on a daily basis.
  • You need to have not taken finasteride or dutasteride within 6 months of visit 2. And not taken topical minoxidil within 12 weeks of visit 2. They need to be able to figure out only Breezula hair growth results via its androgen receptor (AR) antagonist mechanism of action. This requirement may dissuade a majority of hair loss sufferers from participating.

There are a total of 8 inclusion criteria and 14 exclusion criteria that you must read before deciding to volunteer.

Another major issue is that there are various Breezula clinical trial URLs floating around, and past company announcements were a bit confusing about locations. Moreover, even in the below two links, the location section is a scroll-through box where you can only see one location on the screen at a time.

So I am pasting all the 50 locations (across 4 countries) below in the hopes that I can help at least slightly speed up recruitement.

SCALP 1 Locations

United States

Arkansas Locations
North Little Rock, Arkansas, United States, 72116
The Petrus Center for Aesthetic Surgery and Hair Transplantation
Contact: Gary Petrus, MD
Contact: Terri Kim Rogers
+1 501-614-3052 Kim@DrPetrus.com

California Locations
San Diego, California, United States, 92123
Therapeutics Clinical Research
Contact: Neal Bhatia, MD
Contact: Hector A Bailon
+1 858-571-6800 hbailon@therapeuticsresearch.com

Florida Locations
Jacksonville, Florida, United States, 32224
Mayo Clinic, Department of Dermatology
Contact: Alison Bruce, MD
Contact: Matthew Dwarika
+1 904-953-3551 Dwarika.Matthew@mayo.edu

Miami, Florida, United States, 33125
University of Miami
Contact: Mariya Miteva, MD
Contact: Olumide Ojoola, MD
+1 305-243-8205 oxo160@med.miami.edu

Louisiana Locations
Baton Rouge, Louisiana, United States, 70809
DelRicht Research
Contact: Ira Thorla, MD
+1 225-412-0316 info@delricht.com

New Orleans, Louisiana, United States, 70115
DelRicht Research
Contact: Sarah Jackson, MD
+1 504-336-2667 info@delricht.com

Michigan Locations
Detroit, Michigan, United States, 48202
Henry Ford Health
Contact: Linda Stein Gold, MD
Contact: Fanar Razoky
+1 248-219-4304 frazoky1@hfhs.org

Minnesota Locations
Minneapolis, Minnesota, United States, 55455
University of Minnesota
Contact: Maria Hordinsky, MD
Contact: Jaime Nugent
+1 612-625-8625 speck007@umn.edu

Nevada Locations
Las Vegas, Nevada, United States, 89148
JDR Dermatology Research
Contact: James Del Rosso, MD
Contact: Melissa Jacobson
+1 702-964-2425 mj.drdr@gmail.com

New Jersey Locations
Berlin, New Jersey, United States, 08009
Hassman Research Institute
Contact: Michael Hassman, MD
Michael.Hassman@cenexel.com
Contact: Mark Capichana
+1 856-753-7335 m.capichana@cenexel.com

New York Locations
New York, New York, United States, 10022
Diane S. Berson MD, PLLC
Contact: Diane S Berson, MD
Contact: Kiera Murphy
+1 212-355-3511 staff@dianebersonmd.com

Stony Brook, New York, United States, 11790
Derm Research Center of New York, Inc.
Contact: Elyse Rafal, MD
Contact: Dawn D’Angelo
+1 631-880-9660 ddangelo@drcny.com

North Carolina Locations
Charlotte, North Carolina, United States, 28277
On Site Clinical Solutions
Contact: Catherine Pointon, MD
Contact: Alexandra Perez
+1 704-995-1198 aperez@onsiteclinical.com

Texas Locations
Austin, Texas, United States, 78759
DermResearch
Contact: Janet DuBois, MD
Contact: Hadie Mendoza
+1 512-349-9889 hadie@vialtrials.com

Frisco, Texas, United States, 75034
DelRicht Research
Contact: Brent Spencer, MD
+1 927-807-5787 info@delricht.com

San Antonio, Texas, United States, 78213
Progressive Clinical Research
Contact: Mark Lee, MD
Contact: Marta Reyna
+1 210-614-5557 mreyna@progclin.com

Georgia (the country)

Batumi, Georgia, 6000
LTD Health
Contact: Lela Beridze, MD
Contact:
Natia Bezhanidze
+995 597 51 47 34 natiabezhanidze3@gmail.com

Tbilisi, Georgia, 0114
JSC Curatio
Contact: Maia Datuashvili, MD
Contact: Neli Bakuradze
+995 599 90 23 54 Nelly_bakuradze@yahoo.com

Tbilisi, Georgia, 0159
Kanveni National Center of Dermatology and Venerology
Contact: George Galdava, MD
Contact: Victoria Sulava
+995 593 324 578 sulavav@yahoo.com

Tbilisi, Georgia, 0159
Tbilisi Cancer Center
Contact: Lally Mekokishvili, MD
Contact: Nino Kapanadze
+995 577 79 78 06 Ninucakap@yahoo.com

Tbilisi, Georgia, 0160
Aversi Clinic
Contact: Sergo Dadashyan, MD
Contact: Maka Katsia
+995 593 34 32 66 mkatsia@yahoo.com

Tbilisi, Georgia, 0160
Medi Club
Contact: Nino Lortkipanidze, MD
Contact: Mariam Kutidze
+995 595 80 19 89 m.kutidze@mcg.ge

Tbilisi, Georgia, 0179
David Abuladze Georgian-Italian Clinic
Contact: Josephe Kobakhidze, MD
Contact: Tinatin Shaishmelashvili
+995 558 50 75 55 tinatin.shaishmelashvili@gmail.com

Tbilisi, Georgia, 0186
LTD “Medinvestment”
Contact: Irakli Dartsmelia, MD
Contact: Tamar Loseliani
+995 577 73 63 33 tata.ioseliani@gmail.com

SCALP 2 Locations

United States

Arizona Locations
Scottsdale, Arizona, United States, 85255
Investigate MD
Contact: Brenda LaTowsky, MD
+1 480-440-5985 research@investigatemd.com

Florida Locations
Hollywood, Florida, United States, 33021
Physician’s Institute of Cosmetic and Reconstructive Surgery
Contact: Jonathan Weiser, MD
Contact: Wanda Bargot
+1 945-964-4113 wandabargot@yahoo.com

Georgia Locations
Atlanta, Georgia, United States, 30329
DelRicht Research
Contact: Robert Springer, MD
+1 770-417-4454 info@delricht.com

Michigan Locations
Troy, Michigan, United States, 48084
Revival Research Institute
Contact: Ali Moiin, MD
Contact: Sikar Grewal
+1 248-564-1485 grewal@rev-research.com

Warren, Michigan, United States, 48088
Grekin Skin Institute
Contact: Steven Grekin, MD
Contact: Claudia Attala
+1 586-759-5525 claudia.attala@adcsclinics.com

Missouri Locations
Wildwood, Missouri, United States, 63040
DelRicht Research
Contact: Christopher Kling, MD
+1 504-336-2667 info@delricht.com

North Carolina Locations
Huntersville, North Carolina, United States, 28078
Piedmont Plastic Surgery and Dermatology
Contact: Nicole Seminara, MD
Contact: Jeffrey Decker
+1 980-900-9229 Jdecker@onsiteclinical.com

South Carolina Locations
Spartanburg, South Carolina, United States, 29307
Advanced Dermatology & Cosmetic Surgery
Contact: Amylynne Frankel, MD
Contact: Ashley Davis
+1 864-574-0017 ashley.davis@adcsclinics.com

Tennessee Locations
Thompson’s Station, Tennessee, United States, 37179
DelRicht Research
Contact: Pezhman Shoureshi, MD
+1 629-895-1775 info@delricht.com

Texas Locations
Pflugerville, Texas, United States, 78660
Austin Institute for Clinical Research
Contact: Edward Lain, MD
Contact: Xiomara Duarte
+1 512-279-2545 XDuarte@atxresearch.com

Sugar Land, Texas, United States, 77479
Acclaim Dermatology LLC
Contact: Syed Ali, MD
Contact: Carina Espinoza
+1 832-770-6388 carinae@acclaimderm.com

Washington Locations
Spokane, Washington, United States, 99202
Premier Clinical Research
Contact: William P Werschler, MD
Contact: Celeste Gray
+1 509-505-1815 CGray@PremierClinicalResearch.com

Germany

Berlin, Germany, 10117
Clinical Research Center for Hair and Skin Science, Dept. of Dermatology, Venereology and Allergology, Charité – Universitätsmedizin Berlin
Contact: Ulrike Blume-Peytavi, MD
Contact: Annette Andruck
+49 30 450 518 458 annette.andruck@charite.de

Berlin, Germany, 10629
Emovis GmbH
Contact: Guido Burbach, MD
Contact: Julia Welle
+49 (0)30 439741220 julia.welle@emovis.de

Düsseldorf, Germany, 40212
Privatpraxis Dr. Hilton & Partner
Contact: Rodrigo da Mota
Contact: Melanie Momm
+49 (0) 211 86 29 28 90 momm@dr-hilton.de

Freiburg, Germany, 79098
Dermaticum-Privatpraxis für Dermatologie
Contact: Rolf Hoffmann, MD
Contact: Danuta Sobczak
+49 (0) 1702838441 dsobczak@t-online.de

Hamburg, Germany, 20095
Eurofins | bioskin
Contact: Walter Wigger-Alberti, MD
Contact: Sabine Schendel
+49 40 606 89 743 Sabine.Schendel@cpt.eurofinseu.com

Mainz, Germany, 55131
Department of Dermatology and Allergy, Johannes Gutenberg-Universität KöR
Contact: Petra Staubach, MD
Contact: Evelyn Mueller
+49 (0) 6131-17-2944 evelyn.mueller@unimedizin-mainz.de

Poland

Katowice, Poland, 40-081
Centrum Medyczne Pratia
Contact: Kamila Płaczek, MD
Contact: Paulina Majka
+48 721 201 421 paulina.majka@pratia.com

Katowice, Poland, 40-611
Centrum Medyczne Angelius Provita
Contact: Magdalena Kolanko, MD
Contact: Agata Puchowicz
+48 721 210 110 a.puchowicz@angelius.org

Krakow, Poland, 30-033
Centrum Medyczne All-med Badania Kliniczne
Contact: Grażyna Pulka, MD
Contact: Alicja Wolska-Król
+48 12 422 34 271 allmedpl@gmail.com

Kraków, Poland, 31-011
Centrum Nowoczesnych Terapii Dobry Lekarz
Contact: Malgorzata Dyczek, MD
Contact: Katarzyna Gajda
+48 690 000 367 katarzyna.gajda@dobrylekarz.com.pl

Kraków, Poland, 31-559
Diamond Clinic Sp. z o.o.
Contact: Barbara Rewerska, MD
Contact: Aleksandra Kubajewska
+48 571 241 412 a.kubajewska@diamondclinic.eu

Lublin, Poland, 20-412
Pro Life Medica
Contact: Agnieszka Sajdak-Wojtaluk, MD
Contact: Agnieszka Saja-Górecka
+48 537 827 727 a.saja-gorecka@etg-network.com

Warszawa, Poland, 02-637
Narodowy Instytut Geriatrii, Reumatologii iRehabilitacji im. prof. dr hab. med. Eleonory Reicher
Contact: Mariusz Sikora, MD
Contact: Marta Kurek
+48 603 315 033 marta.kurek@spartanska.pl

Warszawa, Poland, 02-661
Carpe Diem Centrum Medycyny Estetycznej
Contact: Weronika Mołga, MD
Contact: Paulina Litkowska
+48 608 888 888 “paulina.litkowska@gmail.com
Łódź, Poland, 90-436

Dermoklinika Centrum Medyczne s.c. M. Kierstan, J.Narbutt, A. Lesiak
Contact: Aleksandra Lesiak, MD
Contact: Małgorzata Szulc
+48 690 056 595 badaniakliniczne@dermoklinika.pl

Breezula, Androgen Receptors, Cassiopea, Clascoterone, Cosmo Pharmaceuticals, Topical Antiandrogen

Breezula Phase III Trials Begin

120 Comments

Breezula® (clascoterone solution) is a novel androgen receptor antagonist that is currently in Phase 3 trials for the treatment of androgenetic alopecia (AGA). If approved, it will be sold by Cosmo Pharmaceuticals NV (Ireland). Breezula was originally called CB-03-01 and manufactured by Cassiopea (Italy), prior to the latter’s 2021 takeover by Cosmo. Breezula product details can be seen here.

I have written about Cassiopea/Cosmo/Breezula in well over a dozen past posts. Feel free to read all of them, going back to the very first one in 2014 when the product was known as CB-03-01. Its key ingredient is known as clascoterone, an androgen receptor (AR) antagonist. Similar to Kintor Pharma’s KX-826 (Pyrilutamide).

Breezula Cosmo Pharma
Breezula from Cosmo Pharmaceuticals.

Update: March 21, 2024

Breezula will come out in 2026 and cost $110 per month

Cosmo Pharma just released a detailed new pdf regarding the company’s 2023 full year performance. Breezula details are from page 31-39. Some great new information that suggests the company is very confident about Breezula (clascoterone) being approved and coming to market at the end of 2026 in the US and EU.

The US launch price will be $110 per month. Cosmo plans to target the existing physician-driven AGA market where doctors usually prescribe their balding patients oral finasteride or OTC topical minoxidil. Breezula expects to capture 35 percent of this market.

Update: March 20, 2024

Breezula Phase 3 Trials Update

Cosmo Pharma just reported excellent full-year 2023 financial results and doubled its dividend payment. More importantly, regarding the Breezula (clascoterone solution) Phase III trial in males for the treatment of androgenetic alopecia:

  1. 348 out of a planned 726 patients have been recruited in study CB-03-01/37.
  2. 507 out of a planned 726 patients have been recruited in study CB-03-01/38.

The Phase 3 trials are across four countries (US, Poland, Germany and Georgia) and 50 centers.

Update: September 13, 2023

Breezula Phase 3 Trial Enrollment Opportunities

Edit: It seems like there are around 30 US locations. You have to scroll through a separate box in the SCALP1 and SCALP2 links above.

================================================

Earlier this week, someone I trust sent me a link in regards to a new androgenetic alopecia related clinical trial that is taking place in New Jersey, US. There are two very interesting keywords in the URL that I was sent:

https://cenexelresearch.com/hri/trials/androgenetic-alopecia/?utm_source=Facebook&utm_medium=Paid&utm_campaign=Cassiopea%20CB-03-01%2F37&utm_content=Dermatology

The shortened version of the link on CenExel clinical research organization (CRO)’s androgenetic alopecia page does not mention the involvement of Cassiopea (or its new owner Cosmo Pharmaceuticals). Neither does it mention any product name.

However, in my last update of this post in June, I mentioned that Cosmo is finally starting its Breezula topical anti-androgen Phase 3 clinical trials in the US and Georgia. A total of 750 males will be enrolled between the two countries. The trials will end in January 2025. The above mentioned trials in New Jersey are almost certainly for Breezula.

Note that you have to be a male of 18 years age or older who has androgenetic alopecia.

Update: June 29, 2023

Cosmo Begins Phase III Trials for Clascoterone (Breezula)

Cosmo Pharmaceuticals just announced the beginning of Phase III trials of clascoterone solution (5%) in males for the treatment of androgenetic alopecia (AGA). The name of this product is Breezula® and it is a novel androgen receptor inhibitor. Trials will involve 750 patients in the US and Georgia. The company’s acne product with the same clascoterone ingredient (but lower dose of 1%) is called Winlevi and is already available in the market.

Key quote:

“If approved by the FDA, clascoterone solution has the potential to be the only topical androgen receptor inhibitor for AGA and the first drug with a new mechanism of action for the treatment of AGA in nearly three decades.”

Update: February 16, 2023

Cosmo Pharma’s latest guidance states the following:

“Cosmo expects to have the first patient enrolled in the Breezula® (Clascoterone solution for androgenetic alopecia) phase III trial in males in Q1 2023.”

Also see Cosmo Pharma’s new page on Breezula. The company took over majority ownership of Cassiopea in December 2021 after being a part-owner for years (see bottom of this post).

Update: October 7, 2020

Cassiopea (Cosmo Pharma) completed enrollment in its Phase II trials for female pattern hair loss. The 6-month study has enrolled 293 patients. The four-arm study will divide volunteers into four treatment groups: clascoterone solution 5% BID (twice daily); clascoterone solution 7.5% BID (twice daily); minoxidil solution 2% BID (twice daily); and vehicle BID (twice daily).

Update: August 27, 2020

Cassiopea’s Winlevi topical androgen receptor inhibitor has just been approved as an acne treatment by the US FDA. It is the first acne treatment with a new mechanism of action to be approved in 40 years. The key ingredient (clascoterone cream 1%) is the same as in the keenly awaited hair loss product Breezula. The latter will have a higher dosage.

CEO Diana Harbort quote:

Dermatologists have said targeting androgen hormonal activity in the skin is ‘the holy grail’ of acne treatment for both males and females.

I expect Breezula will not come to the market till 2023, assuming it gets final approval. However, some people plan to use Winlevi on the scalp, even though this is not recommended by the manufacturer.

Update: March 19, 2020

Phase 3 Trials Delay

How things can change in just a few weeks. Breezula Phase 3 trials have now been delayed till 4th quarter 2020 or 1st quarter 2021. All due to COVID-19 (Coronavirus), which has hit Italy particularly hard. More information can be found in Cassiopea’s 2019 Annual Report which was released today.

The Clascoterone female pattern hair loss Phase 2 trials are on track to finish enrollment in 2Q 2020. Trials should be completed by year-end 2020. However, delays are still possible depending on progression and recurrence of the current pandemic.

Quote from the accompanying pdf:

“As part of the process in the NDA review, the FDA amongst other, also inspects the facility in which Clascoterone cream 1% is manufactured. Clascoterone cream 1% is planned to be manufactured at Cosmo Pharmaceuticals plant in Lainate in Italy. Given restrictions currently in place because of the COVID-19, the FDA had to postpone the inspection planned for March.”

Nevertheless, Cassiopea is still planning to release its Winlevi acne cream product by the end of this year.

Update November 13, 2019: Cassiopea’s women’s hair loss clascoterone solution Phase II trials starting soon in Germany.

April 16, 2019

Cassiopea (Cosmo Pharmaceuticals)

I have covered Italian company Cassiopea since 2014 (when it was called Cosmo Pharmaceuticals). The company is developing a topical anti-androgen hair loss product named Breezula (originally called CB-03-01). The chemical name for this product is Clascoterone. Note that Cosmo Pharma still owns 45 percent of Cassiopea.

Breezula will be available for both men and women. Several of my well known physician contacts in the hair loss world have told me great things about this product. Their feedback is based on what they saw at conferences or heard from colleagues.

Breezula Phase II Trials Very Successful

In July of last year, Cassiopea stated that the interim Phase II clinical trial results for Breezula were very positive. Today, they released twelve month Phase II trial results with the same conclusion:

Cassiopea announces very positive Phase II Twelve Months Results for Breezula® (Clascoterone) in treating androgenetic alopecia.

The presentation of the results is confusing, detailed, full of acronyms and somewhat open to interpretation. Note that “BID” in there stands for “twice per day” after conversion from Latin. Hopefully they release before and after photos at some point.

Also note that the previous 6-month interim report had 375 subjects, and the 12-month report has 344 subjects. The trial was conducted in Germany.

Breezula Target Area Hair Count Increase

Breezula Hair Count Increase
Breezula Hair Count Increase.

Best case result highlighted in yellow (14.3 new hairs per square centimeter, after 12 months of 7.5% BID clascoterone solution dosage). BID means twice per day.

Breezula Target Area Hair Width Increase

Breezula Hair Width Increase
Breezula Hair Width Increase.

Best case result highlighted in yellow (762.5 um width increase, after 12 months of 7.5% BID dosage).

My gut feeling is that Breezula will be at least as effective as Finasteride and Minoxidil.

Clascoterone Summary

Some key points from the above linked article from Cassiopea:

  • If approved, Breezula (Clascoterone) will be the first FDA-approved topical anti-androgen for the treatment of androgenetic alopecia.
  • Moreover, it would also be the first new drug approved for treating androgenetic alopecia since 1997. That year was when Propecia (aka Finasteride) was first approved to treat hair loss. That year was also when Tiger Woods first won the Master’s golf tournament. His 5th surprise victory in that tournament came this past weekend.
  • Based on these great results, Cassiopea plans to proceed with 6-month Phase III trials in men in the fourth quarter of 2019, after consultation with the FDA. The company is also going to start proof-of-concept trials in women.
  • Breezula works by blocking dihydrotestosterone (DHT) interaction with hair follicle androgen receptors.
  • Clascoterone does not interfere with testosterone and other hormones in male subjects. Libido and sexual behavior changes have so far not been observed in clinical trials. Moreover, due to its rapid metabolism and localized activity, Clascoterone (Breezula) does not produce any systemic side effects.

In the past, I used to often state that perhaps an initial cure for hair loss would entail the usage of a cocktail of products. Each working via different mechanisms and chemical or biological reactions.

It is looking likely that Breezula will be one of the main products in this cocktail.

Note that Clascoterone 1% cream to treat acne will be released by Cassiopea before Breezula. The acne product is called Winlevi.