||
Chong Kun Dang Bio’s botulinum toxin product “Timbers Inj.” is entering clinical development in the United States as a <a href="https://healthylife7.com/who-updates-treatment-guidelines-on-visceral-and-post-kala/” title=”WHO updates treatment guidelines on visceral and post-kala”>treatment for major depressive disorder. The plan is to expand the use of botulinum toxin, previously used in aesthetic procedures, into the field of neuropsychiatric treatment
Chong Kun Dang Bio said on the 30th that the U.S. Food and Drug Administration (FDA) had approved a Phase 1 clinical trial plan for the major depressive disorder indication of Timbers Inj. 100 units
The trial will be conducted by Chong Kun Dang Bio’s U.S. development partner, Healis Therapeutics, while Chong Kun Dang Bio plans to handle the production and supply of the investigational drug. Healis Therapeutics plans to conduct the trial by administering a single dose of Timbers Inj. to healthy adults and then gradually increasing the dosage. Through this, it will evaluate the drug’s safety, tolerability, and pharmacodynamic characteristics
Based on the Phase 1 results, the two companies plan to pursue follow-up trials targeting various neuropsychiatric patients, including those with major depressive disorder. They are also reviewing plans to broaden the indications to other neuropsychiatric disorders such as post-traumatic stress disorder and social anxiety disorder
Timbers Inj. is a botulinum toxin product that Chong Kun Dang Bio produces based on a strain introduced from a German institution. It does not use human serum albumin derived from human blood and has also obtained halal certification. Following the existing 100-unit product, Chong Kun Dang Bio plans to launch a 200-unit product next month
“This clinical approval is an important opportunity to confirm the potential of Timbers Inj. to be used as a treatment beyond the aesthetics field,” a Chong Kun Dang Bio official said. “We will cooperate with Healis Therapeutics to support clinical development.”
#ChongKunDangBio#BotulinumToxin#Depression#FDA#ClinicalTrial#Neuropsychiatry#KoreaBio
Original reporting by Lee Yeon-soo for Seoul Economic Daily
AI-translated from Korean. Quotes from foreignxact original wording
View Korean originalTranslation Policy
More →
Most Read This Week
1-5
- 1Spouses of Dementia Patients Face 70% Higher Risk, Study Finds
- 2Typhoon Dolphin Heads North Toward Japan After Magnitude 7.1 Quake
- 3Samsung, Broadcom Sign $200 Billion Chip Supply Deal, Presidential Office Says
- 4Toyota’s Best-Selling RAV4 Grows Stronger with PHEV Powertrain
- 5KOSPI Reclaims 7,000 on Chip Stock Strength
← Back to Home
