Botanix Sofdra Earns First Hyperhidrosis Seal in 20 Years

Botanix Sofdra Hyperhidrosis Recognition: the underarm sweating gel has won the International Hyperhidrosis Society's Seal of Recognition, the first time in 20 years the award has been given.
By Josua Ferreira -
  • Sofdra has won the International Hyperhidrosis Society Seal of Recognition, which the company says is the first time in 20 years it has been awarded.
  • The seal is given to products backed by strong clinical evidence, rigorous testing and responsible marketing.
  • Botanix is placing new materials in dermatology waiting areas and exam rooms during Hyperhidrosis Awareness Month this November.
  • More than 16 million Americans have hyperhidrosis, yet only about half raise it with their doctor.
  • Patent protection runs into May 2040, and a second supplier under a Piramal term sheet is meant to lower costs.
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Sofdra earns International Hyperhidrosis Society Seal of Recognition

Botanix Pharmaceuticals (ASX:BOT) announced on 10 November 2026 that Sofdra® (sofpironium) topical gel, 12.45% is a recipient of the International Hyperhidrosis Society (IHhS) Seal of Recognition™. According to the company, this is the first time in 20 years that the recognition has been awarded.

IHhS is a US-based non-profit organisation dedicated to people living with hyperhidrosis, or excessive sweating. With the award, Sofdra is “Recognized by the International Hyperhidrosis Society for Research & Rigor in Helping Combat Excessive Sweating™.”

The award highlights products, devices and procedures validated by:

  • Strong scientific and clinical evidence
  • Rigorous testing
  • Demonstrated efficacy and tolerability
  • Responsible marketing communications

For investors, the recognition is independent validation of Sofdra’s evidence base and marketing conduct.

IHhS Seal of Recognition: Validation Criteria

Independent validation of the evidence base sits alongside a widening intellectual property estate, with a recent US patent allowance covering the crystalline form of the drug substance and protection running into May 2040.

Dr Howie McKibbon, Chief Executive Officer, Botanix

“…IHhS has long been the champion of people living with hyperhidrosis, so this recognition carries real meaning for Botanix.”

Hyperhidrosis Awareness Month support in dermatology offices

The recognition arrives at the start of Hyperhidrosis Awareness Month, which IHhS has led each November. Botanix is supporting the month with:

  • Increased promotion in dermatology offices to raise awareness of primary axillary hyperhidrosis (excessive underarm sweating) and Sofdra
  • New materials placed in physicians’ waiting areas and exam rooms
  • Materials designed to help patients self-identify their condition and prompt conversations between physicians and patients

Hyperhidrosis affects more than 16 million Americans, according to the company. Many people do not recognise it as a medical condition, and only around half raise it with their doctor.

Botanix describes Sofdra as the first and only new chemical entity approved by FDA to treat primary axillary hyperhidrosis.

On the cost side, a second API supplier under a Piramal term sheet is intended to lower cost of goods sold and reduce reliance on a single manufacturing partner as volumes grow.

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Frequently Asked Questions

What is the International Hyperhidrosis Society Seal of Recognition?

It is an award from a US non-profit for people living with excessive sweating. It highlights products backed by strong clinical evidence, rigorous testing, proven results and responsible marketing.

What is hyperhidrosis?

Hyperhidrosis is the medical term for excessive sweating. The company says it affects more than 16 million Americans, and many do not see it as a medical condition.

What is Sofdra and who makes it?

Sofdra is a topical gel made by Botanix Pharmaceuticals to treat excessive underarm sweating. The company describes it as the first and only new chemical entity approved by the FDA for this condition.

What is Botanix doing for Hyperhidrosis Awareness Month?

Botanix is promoting Sofdra more in dermatology offices and placing new materials in waiting areas and exam rooms. The materials help patients recognise their condition and talk to their doctor.

How long does patent protection for Sofdra last?

The company says a recent US patent allowance covers the crystalline form of the drug substance, with protection running into May 2040.

Josua Ferreira
By Josua Ferreira
Partnership Director
Josua Ferreira holds a Bachelor of Commerce in Marketing and Advertising and brings a background in publication, business development, and ASX market storytelling. He has worked with listed companies across the resource sector and broader market, combining sharp commercial instincts with a genuine commitment to keeping investors informed.
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