Ipsen announced that its neurotoxin Dysport achieved the primary goals in two Phase 3 clinical trials evaluating the treatment for the prevention of episodic and chronic migraine. According to the company, Dysport is the first botulinum toxin to report positive Phase 3 results in episodic migraine while also demonstrating positive results in chronic migraine.
The findings come from Ipsen’s Beond clinical program, which enrolled a total of 1,510 patients across two studies. The C-Beond trial evaluated patients with chronic migraine, while the E-Beond study focused on episodic migraine. Both trials met their primary endpoints, showing a statistically significant reduction in monthly migraine days compared with placebo.
Commenting on the results, Christelle Huguet, Ph.D., Ipsen’s global head of research and development, said: “Together, these findings position Dysport as a potential first-in-class treatment for a broad migraine population.”
Ipsen said it will review the complete data from the studies and prepare regulatory submissions. A company spokesperson stated that the planned filings include submissions to the U.S. Food and Drug Administration.
The company noted that episodic migraine represents a substantially larger patient population than chronic migraine. In the E-Beond trial, episodic migraine was defined as patients experiencing no more than 14 headache days per month, including at least six migraine days. While definitions of episodic and chronic migraine can vary, the threshold of 14 headache days per month is described as a widely accepted standard.
The positive trial results come in a market where AbbVie’s Botox has been approved by the FDA since 2010 to prevent headaches in patients with chronic migraine. Ipsen stated that the clinical outcome gives the company another venue to chip away at Botox’s dominance. Botox generated nearly $6.4 billion in sales last year across therapeutic and cosmetic indications.
By comparison, Ipsen reported Dysport revenues in 2025 of 298 million euros, or approximately $341 million, and 436 million euros, or about $500 million, across therapeutic and aesthetic fields, respectively. Dysport was first approved by the FDA in 2009 for cervical dystonia and glabellar lines and is also indicated for certain patients with spasticity.
Migraine, including episodic and chronic forms, affects around 14% to 15% of the global population. Beyond Dysport, Ipsen is developing a recombinant neurotoxin known as corabotase (IPN10200). The candidate is in Phase 2 development for migraine and has already advanced into Phase 3 in aesthetics.
In the Phase 2 Lantic aesthetics study, Ipsen reported that corabotase provided a significantly longer duration of effect than Dysport in achieving a score of “none” or “mild” line severity at week 24.
Corabotase was also at the center of a dispute between Ipsen and its long-time commercialization partner Galderma. The disagreement involved control of next-generation neuromodulator projects after Ipsen moved to terminate a research and development partnership signed in 2014. In January 2026, the arbitral tribunal of the International Chamber of Commerce issued a final decision in Ipsen’s favor, allowing the company to end the agreement and take full control of its clinical-stage toxin programs in the aesthetic field. The dispute did not affect the companies’ commercialization collaboration related to Dysport.
Positive Phase 3 Results Position Dysport as a Promising Preventive Migraine Therapy
Dysport has successfully achieved the primary objectives in Phase 3 clinical trials evaluating its effectiveness in treating both episodic and chronic migraine. The encouraging results represent an important milestone for the therapy and could expand treatment options for millions of patients who experience frequent migraine attacks.
The positive findings demonstrate the potential of Dysport as a preventive therapy capable of reducing migraine frequency while maintaining a favorable safety profile. Following these results, the developer is expected to pursue regulatory submissions in key global markets.
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