Letybo® (Le-tye-boe) is only the 6th neuromodulator to receive approval by the U.S. FDA in over 20 years.
MISSION VIEJO, CA, USA I March 25, 2025 I With proven results backed by extensive clinical research, Letybo is a globally trusted brand for over a decade, ranking as the #1 neuromodulator in South Korea1. With over 29 peer reviewed studies on the active ingredient letibotulinumtoxinA, it’s approved in over 65 countries with over 31 million successful treatments to date.
Letybo is now fully commercialized in the U.S. through the partnership between BENEV and Hugel, marking a significant milestone in the neuromodulator market. As only the 6th neuromodulator to gain FDA approval in more than 20 years, Letybo offers U.S. providers a trusted solution for glabellar lines backed by robust clinical data and a proven global track record.
“We are honored to join forces with Hugel to bring Letybo to the U.S. market,” stated Ethan Min, Chief Executive Officer at BENEV. “This partnership with Hugel allows us to strengthen our market position and fulfill our mission to BENefit EVeryone through transformative aesthetic solutions.”
According to Dr. Hyoung Jin Moon, Representative Executive Officer of Hugel, Inc., “We are delighted to embark on the Letybo journey with BENEV. Our shared philosophies, including a commitment to provide premium products and education, science and technology, position us to offer a compelling service to the market. This partnership with BENEV will solidify Hugel’s position as a leader in the global medical aesthetics market.”
BENEV has been at the forefront of introducing science-backed aesthetic advancements from South Korea – a global leader in beauty innovation – to US aesthetic practices, and Letybo joins BENEV’s impressive portfolio of K-beauty inspired solutions.
To stay connected on the latest updates, follow us on Instagram at Letybo.USA or go to LetyboUSA.com for more information.
- LetibotulinumtoxinA, the active ingredient. Data on file. Based on total reported revenue 2016-2024, Hugel, Inc.
APPROVED USE
LETYBO is a prescription medicine for adults that is injected into muscles to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).
IMPORTANT SAFETY INFORMATION
LETYBO may cause serious side effects that can be life threatening. Call your healthcare provider or get medical help right away if you have any of these problems after treatment with LETYBO:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms that include loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.
Do not receive LETYBO® if you are allergic to any of the ingredients in LETYBO (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as MYOBLOC® (rimabotulinumtoxinB), BOTOX®/BOTOX® COSMETIC (onabotulinumtoxinA), DYSPORT® (abobotulinumtoxinA), XEOMIN® (incobotulinumtoxinA), JEUVEAU® (prabotulinumtoxinA-xvfs), or DAXXIFY® (daxibotulinumtoxinA-lanm); or have a skin infection at the planned injection site.
LETYBO dosing units are not the same as, or comparable to, any other botulinum toxin product.
Tell your healthcare provider about all your medical conditions, including side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles, drooping eyelids; have had surgery on your face; are pregnant or breastfeeding or plan to become pregnant or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using LETYBO with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your healthcare provider that you have received LETYBO in the past.
Especially tell your healthcare provider if you have received any other botulinum toxin product in the last 4 months or any in the past, and exactly which product you received (such as MYOBLOC®, BOTOX®/BOTOX® COSMETIC, DYSPORT®, XEOMIN®, JEUVEAU®, or DAXXIFY®). LETYBO may cause serious side effects, including allergic reactions (such as itching, rash, hives, wheezing, trouble breathing, or dizziness or feeling faint), heart problems (such as irregular heartbeat and heart attack), and eye problems (including dry eye, reduced blinking, and corneal problems). Tell your healthcare provider or get help right away if you experience a serious side effect. No serious side events of distant spread of toxin effect associated with dermatologic use of LETYBO have been reported in clinical studies at the dose of 20 Units for glabellar lines. The most common side effect of LETYBO was headache.
These are not all the possible side effects of LETYBO. For more information, see the full Prescribing Information including Boxed Warning, and refer to the Medication Guide or talk with your doctor. To report side effects associated with LETYBO, please call 1-877-390-2906. You may also report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
About BENEV Company Inc.
BENEV, established in California in 2000, is an FDA-registered drug manufacturer, specializing mainly in topical solutions for skin and hair, including its exosome products, as well as innovative medical devices such as PDO threads and radiofrequency microneedling device, in the U.S. and around the world. BENEV is an established player in the medical aesthetic market emphasizing health, longevity, and beauty-related products in the U.S., Asia and other markets around the world. BENEV has a fully integrated business model, which includes manufacturing, research and development, sales, and marketing.
About Hugel Inc.
Established in 2001, Hugel is a global leader in medical aesthetics, specializing in the production of injectables for skin rejuvenation, including botulinum toxin, hyaluronic acid fillers, and skin boosters, as well as absorbable sutures and cosmetic products. As the market leader in injectable aesthetics in South Korea, Hugel is the only South Korean company with regulatory approvals in the world’s three largest botulinum toxin markets: the US, China, and Europe. With a proven track record of safety and quality, Hugel is deeply committed to advancing the industry through robust medical affairs, comprehensive training programs, and dynamic industry forums. Over the past 20 years, the company has built a presence in approximately 70 countries and operates eight global subsidiaries across South Korea, the US, Australia, Canada, Taiwan, China, Hong Kong, and Singapore. Leveraging strong industry momentum, Hugel is poised for continued growth and global market expansion.
For Press Inquiries: Letybomarketing@benev.com
SOURCE: BENEV Company
Post Views: 621
Letybo® (Le-tye-boe) is only the 6th neuromodulator to receive approval by the U.S. FDA in over 20 years.
MISSION VIEJO, CA, USA I March 25, 2025 I With proven results backed by extensive clinical research, Letybo is a globally trusted brand for over a decade, ranking as the #1 neuromodulator in South Korea1. With over 29 peer reviewed studies on the active ingredient letibotulinumtoxinA, it’s approved in over 65 countries with over 31 million successful treatments to date.
Letybo is now fully commercialized in the U.S. through the partnership between BENEV and Hugel, marking a significant milestone in the neuromodulator market. As only the 6th neuromodulator to gain FDA approval in more than 20 years, Letybo offers U.S. providers a trusted solution for glabellar lines backed by robust clinical data and a proven global track record.
“We are honored to join forces with Hugel to bring Letybo to the U.S. market,” stated Ethan Min, Chief Executive Officer at BENEV. “This partnership with Hugel allows us to strengthen our market position and fulfill our mission to BENefit EVeryone through transformative aesthetic solutions.”
According to Dr. Hyoung Jin Moon, Representative Executive Officer of Hugel, Inc., “We are delighted to embark on the Letybo journey with BENEV. Our shared philosophies, including a commitment to provide premium products and education, science and technology, position us to offer a compelling service to the market. This partnership with BENEV will solidify Hugel’s position as a leader in the global medical aesthetics market.”
BENEV has been at the forefront of introducing science-backed aesthetic advancements from South Korea – a global leader in beauty innovation – to US aesthetic practices, and Letybo joins BENEV’s impressive portfolio of K-beauty inspired solutions.
To stay connected on the latest updates, follow us on Instagram at Letybo.USA or go to LetyboUSA.com for more information.
- LetibotulinumtoxinA, the active ingredient. Data on file. Based on total reported revenue 2016-2024, Hugel, Inc.
APPROVED USE
LETYBO is a prescription medicine for adults that is injected into muscles to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).
IMPORTANT SAFETY INFORMATION
LETYBO may cause serious side effects that can be life threatening. Call your healthcare provider or get medical help right away if you have any of these problems after treatment with LETYBO:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms that include loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.
Do not receive LETYBO® if you are allergic to any of the ingredients in LETYBO (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as MYOBLOC® (rimabotulinumtoxinB), BOTOX®/BOTOX® COSMETIC (onabotulinumtoxinA), DYSPORT® (abobotulinumtoxinA), XEOMIN® (incobotulinumtoxinA), JEUVEAU® (prabotulinumtoxinA-xvfs), or DAXXIFY® (daxibotulinumtoxinA-lanm); or have a skin infection at the planned injection site.
LETYBO dosing units are not the same as, or comparable to, any other botulinum toxin product.
Tell your healthcare provider about all your medical conditions, including side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles, drooping eyelids; have had surgery on your face; are pregnant or breastfeeding or plan to become pregnant or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using LETYBO with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your healthcare provider that you have received LETYBO in the past.
Especially tell your healthcare provider if you have received any other botulinum toxin product in the last 4 months or any in the past, and exactly which product you received (such as MYOBLOC®, BOTOX®/BOTOX® COSMETIC, DYSPORT®, XEOMIN®, JEUVEAU®, or DAXXIFY®). LETYBO may cause serious side effects, including allergic reactions (such as itching, rash, hives, wheezing, trouble breathing, or dizziness or feeling faint), heart problems (such as irregular heartbeat and heart attack), and eye problems (including dry eye, reduced blinking, and corneal problems). Tell your healthcare provider or get help right away if you experience a serious side effect. No serious side events of distant spread of toxin effect associated with dermatologic use of LETYBO have been reported in clinical studies at the dose of 20 Units for glabellar lines. The most common side effect of LETYBO was headache.
These are not all the possible side effects of LETYBO. For more information, see the full Prescribing Information including Boxed Warning, and refer to the Medication Guide or talk with your doctor. To report side effects associated with LETYBO, please call 1-877-390-2906. You may also report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
About BENEV Company Inc.
BENEV, established in California in 2000, is an FDA-registered drug manufacturer, specializing mainly in topical solutions for skin and hair, including its exosome products, as well as innovative medical devices such as PDO threads and radiofrequency microneedling device, in the U.S. and around the world. BENEV is an established player in the medical aesthetic market emphasizing health, longevity, and beauty-related products in the U.S., Asia and other markets around the world. BENEV has a fully integrated business model, which includes manufacturing, research and development, sales, and marketing.
About Hugel Inc.
Established in 2001, Hugel is a global leader in medical aesthetics, specializing in the production of injectables for skin rejuvenation, including botulinum toxin, hyaluronic acid fillers, and skin boosters, as well as absorbable sutures and cosmetic products. As the market leader in injectable aesthetics in South Korea, Hugel is the only South Korean company with regulatory approvals in the world’s three largest botulinum toxin markets: the US, China, and Europe. With a proven track record of safety and quality, Hugel is deeply committed to advancing the industry through robust medical affairs, comprehensive training programs, and dynamic industry forums. Over the past 20 years, the company has built a presence in approximately 70 countries and operates eight global subsidiaries across South Korea, the US, Australia, Canada, Taiwan, China, Hong Kong, and Singapore. Leveraging strong industry momentum, Hugel is poised for continued growth and global market expansion.
For Press Inquiries: Letybomarketing@benev.com
SOURCE: BENEV Company
Post Views: 621
