Meet Dermatox, the Latest Neurotoxin Up for FDA Approval

Clinic BusinessMeet Dermatox, the Latest Neurotoxin Up for FDA ApprovalWe've officially entered the age of new injectables. 

By Audrey Noble

April 20, 2022

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The year 2022 is gearing up to be the year of facial injections. Right on the heels of the introduction of Daxi, a longer-lasting neurotoxin that's waiting for approval from the U.S. Food and Drug Administration (FDA) is yet another a new neurotoxin that's being touted as a true game-changer in aesthetic treatments: Dermatox.

"With Aquavit's proven track record of developing and launching a global brand such as Aquagold, combined with our network of physicians and knowledge of botulinum toxins, we are poised to make a significant impact in the fast-growing multi-billion-dollar neurotoxin market," writes Sobin Chang, the CEO of Aquavit (the parent company of Dermatox), in a press release. "We plan to introduce the most innovative botulinum toxin programs to uplift and modernize the treatment paradigm."

Dermatox, which is shorthand for DTX-021, is yet another neurotoxin aimed to treat glabellar lines — also known as the "11s" — on the forehead. With Aquavit's submission for approval by the FDA, the injectable joins a new wave of neurotoxins being introduced into the fast-growing non-invasive treatment market.

"The neuromodulator arena is a billion-dollar industry," says Michele Koo MD, board-certified aesthetic plastic surgeon and founder of Dr. Koo Private Practice. "The medical applications are even greater than [those solely] cosmetic. There are still relatively few players in this space, and if Aquavit has a better product for various medical and cosmetic applications, they'll have a unicorn."

"Where there is increasing demand there is increasing growth in technology," adds Jeannette Graf MD, a board-certified dermatologist and assistant clinical professor of dermatology at Mount Sinai School of Medicine. "The noninvasive cosmetic market has grown and will continue to grow exponentially with Botox leading the way."

So what makes Dermatox different from the rest? The truth is that there isn't much detail on the product as of yet, as Aquavit just submitted Dermatox's Investigation of New Drug (IND) to the FDA for approval. Once it passes, more details will be released on what it can actually do. So to get some insight on how the new neurotoxin may work, we turned to the experts to break it all down. 

Meet The Experts:

• Michele Koo MD, a board-certified aesthetic plastic surgeon and founder of Dr. Koo Private Practice in St. Louis, Missouri.
• Jeannette Graf MD, a board-certified dermatologist and assistant clinical professor of dermatology at Mount Sinai School of Medicine New York City.

What is Dermatox and what does it do?

As previously mentioned, Dermatox is a new botulinum toxin that will treat moderate to severe glabellar lines when injected into the face, according to a press release by Aquavit. It's described as a "highly purified and clinically tested injectable neuromodulator" that contains a protein complex derived from the neurotoxins produced by Clostridium botulinum.

Dr. Koo further explains that it will block the targeted muscle at the nerve to prevent muscular contraction, similar to other neurotoxins on the market. "DTX-021 is a botulinum toxin type A similar to Allergan's Botox," she says. "Its mechanism of action is the same."

You can also expect Dermatox to be injected in the same places on the face as other neurotoxin injections that are used to treat frown lines, like around the eyebrows and mouth.

What are the benefits of Dermatox?

Since Dermatox will have a similar function to other neurotoxins, Dr. Koo says you can presume that it will decrease and moderate animation lines in the face. That means, in non-science speak, that it will smooth fine lines and wrinkles in the areas we mentioned above (i.e., the 11s).

How is it different from other neuromodulators?

There's not a lot of official info on the differences between Dermatox and other neurotoxins yet. Dr. Koo assumes that once Dermatox passes phase II of clinical trials, we'll get more detail about what exactly makes it different. But for right now, it's all just speculation.

"I suspect there may be less protein associated with the Botox during the manufacturing process to lessen immunogenicity," she says. "Earlier time to onset, more predictability with results, less diffusion, and longer duration are all goals of any neuromodulator."

"In their early studies, Aquavit has claimed it is highly purified and potent, but it is proprietary information, and there are no comparable data available to other toxins," adds Dr. Graf.

Are there any downsides?

Because it works similar to other neurotoxins made to treat glabellar lines, both Dr. Graf and Dr. Koo predict that you can expect the same possible side effects, such as bruising, swelling, and soreness. Dr. Koo explains that Dermatox has already passed phase I of clinical trials, therefore it is presumed safe. Once the injection passes phase II, it will further validate its safety and efficacy.

Dr. Graf adds that you should probably avoid Dermatox if you've experienced serious negative effects from other neurotoxins. She also recommends that those who are currently pregnant or breastfeeding should avoid this treatment. Otherwise, it should be generally safe.

How close is it to being approved by the FDA?

Aquavit just recently submitted its Investigation of New Drug (IND) to the FDA for approval. Once it is approved, Dr. Graf says that Aquavit will initiate a long-term phase II clinical trial. Dr. Koo adds that phase II studies usually take up to two years. She suspects that Dermatox may lay the groundwork for another new neurotoxin Aquavit hopes to introduce into the market: Microtox.

"Aquavit is accelerating its clinical development program by introducing DTX-022 (to be marketed as Microtox™) shortly after DTX-021," writes Aquavit in the same press release. 

Stay tuned for more on this new injection. Once approved, it might change the landscape of aesthetic treatments as we know it.

Read more about injectables: 

• The Ultimate Guide to Lip Filler
• The 7 Biggest Plastic Surgery Trends of 2022
• Undereye Filler Makes Dark Circles Disappear, But Proceed With Caution

Now, watch Hailey Rhode Bieber's beauty commandments: 

Audrey Noble is a former digital beauty reporter at Allure whose writing explores beauty, culture, and entertainment, spanning topics from race and gender to celebrities and trends. In addition to holding editorial positions at Vanity Fair, Refinery29, and Byrdie, Audrey's work has appeared in Vogue, Harper's BAZAAR, Cosmopolitan, and... Read moreFormer Digital Beauty Reporter

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KeywordsinjectablesBotoxhyaluronic acidfillersplastic surgerycosmetic surgerydermatologistFDA approvalNews