Hsinchu, Taiwan – February 9, 2026 – OBIGEN PHARMA INC. (Ticker: 7876.TWO), Taiwan’s first botulinum toxin innovator, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Phase II Investigational New Drug (IND) application for OBI-858, its novel long-acting botulinum toxin type A (BoNT-A) candidate, for the treatment of moderate-to-severe glabellar lines.
Glabellar lines are vertical frown lines that appear between the eyebrows as a result of repeated contraction of the corrugator and procerus muscles. Botulinum toxin injections are widely used to temporarily relax these muscles, reducing the appearance of moderate-to-severe glabellar lines and improving facial aesthetics.
The FDA acceptance enables OBIGEN to initiate a Phase II clinical study in the United States, representing a key regulatory milestone and a significant step toward global development of OBI-858. The IND submission followed completion of pre-IND interactions with the FDA and was submitted in early January 2026.
OBI-858 is a differentiated, patented 760 kDa BoNT-A complex designed to deliver extended duration of effect and a favorable safety and immunogenicity profile. In a randomized, double-blind, placebo-controlled Phase II clinical study conducted in Taiwan in subjects with moderate-to-severe glabellar lines, OBI-858 demonstrated a fast onset of effect as early as Day 3, durable aesthetic efficacy maintained for at least six months, and no treatment-related serious adverse events or anti-drug antibody development. The results were published in a peer-reviewed international journal (1).
In parallel with U.S. regulatory progress, OBIGEN has initiated two pivotal Phase III clinical trials in Taiwan for the aesthetic glabellar lines indication (2). The trials will enroll approximately 600 patients across 16 medical centers, with the first patient enrolled in December 2025. These studies are designed to support future regulatory filings and commercialization plans.
OBI-858 is manufactured using a scalable, PIC/S GMP-compliant process and is Halal-certified, providing a meaningful differentiation for global markets, including the Middle East and Southeast Asia. The program also offers long-term platform optionality, with potential expansion into therapeutic indications such as spasticity and movement disorders using the same core toxin and manufacturing infrastructure.
Industry estimates project continued strong growth in the global botulinum toxin market over the coming decade, driven by increasing demand for minimally invasive aesthetic procedures and interest in longer-lasting formulations. Long-acting formulations are expected to become the new standard, creating a significant opportunity for OBI-858 to capture market share through strategic partnerships.
OBIGEN, together with its global partnering advisor KYBORA, will be available to engage in strategic discussions with potential regional and global partners regarding the development and commercialization of OBI-858. The team will be present at BIO-Europe Spring (March 23–25, 2026, Lisbon) and the Aesthetic & Anti-Aging Medicine World Congress (March 26–28, 2026, Monaco).
Why Partner with OBIGEN?
Strategically, OBI-858 may be relevant for partners looking to:
For partnership inquiries, please contact:
Patricia Chou
OBIGEN PHARMA INC.
Chief Executive Officer
Email: patriciachou@obigenpharma.com
Website: https://www.obigenpharma.com
Additional partnering contact:
Dr. Jean Chatellier, PhD
KYBORA (Global Partnering Advisor)
Partner, Executive Vice President & Senior Managing Director
Email: jean@kybora.com
Website: https://kybora.com
About OBIGEN PHARMA INC. – OBIGEN PHARMA INC. is Taiwan’s first biotechnology company dedicated to the research, development, and manufacturing of botulinum toxin products. Leveraging proprietary strain selection, advanced fermentation, and high-purity protein isolation technologies, OBIGEN has built a fully integrated value chain from API production to sterile injectable formulation. Our flagship product, OBI-858, is a next-generation, long-acting botulinum toxin with a unique 760 kDa molecular structure, designed to deliver faster onset, longer duration, and improved safety. Supported by a robust global IP portfolio, Halal certification, and PIC/S GMP-compliant facilities, OBIGEN is positioned to expand across Asia, the Middle East, the U.S., Latin America, and Europe through strategic partnerships and licensing opportunities.
About KYBORA – KYBORA is a global advisory firm and investment bank whose mission is to guide transformative healthcare companies to enduring success globally. We provide M&A, licensing, fundraising, and strategic advisory services to the global healthcare industry, creating value for our clients worldwide. With offices in the US, Switzerland, and China, and a direct presence in all key biopharma markets around the world, KYBORA offers unparalleled global reach and local knowledge.
(1) Yen, YH., Tsau, TW., Lee, CH. et al. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of OBI-858 for the Treatment of Moderate-to-Severe Glabellar Lines. Dermatol Ther (Heidelb) 15, 3717–3731 (2025). https://doi.org/10.1007/s13555-025-01561-5
(2) January 7, 2026 - OBIGEN PHARMA Inc. Launches Phase III Clinical Trial of World’s First 760 kDa Long-Acting Botulinum Toxin OBI-858 in Taiwan https://www.obigenpharma.com/en/announcements/announcements-16