In a first for the neurotoxin market, Ipsen announced Thursday that its Dysport has hit the goals in two phase 3 trials for the prevention of both episodic and chronic migraines.
While AbbVie’s market-leading Botox has been approved by the FDA to prevent headaches in patients with chronic migraine since 2010, Dysport is now the first botulinum toxin to also report positive phase 3 results in episodic migraine, according to Ipsen.
The readouts come from studies in Ipsen’s Beond program of altogether 1,510 patients split between C-Beond (chronic) and E-Beond (episodic). Both trials have met their primary endpoints, showing a statistically significant reduction in monthly migraine days versus placebo.
“Together, these findings position Dysport as a potential first-in-class treatment for a broad migraine population,” Ipsen’s global head of R&D, Christelle Huguet, Ph.D., said in a July 9 statement.
Ipsen will review the full data and prepare for regulatory filings, including with the FDA, a company spokesperson told Fierce Pharma.
Episodic migraine represents a “substantially larger patient population” than chronic patients, Ipsen pointed out. The E-Beond trial defines episodic migraine as patients experiencing no more than 14 headache days per month, including at least six migraine days. Specific definitions of episodic versus chronic migraine may vary, but the 14-headache-day per-month cutoff is a widely accepted standard.
The clinical victory gives Ipsen another venue to chip away at Botox’s dominance. The AbbVie blockbuster pulled in nearly $6.4 billion in sales last year across therapeutic and cosmetic indications. By comparison, Ipsen recorded 298 million euros ($341 million) and 436 million euros (about $500 million) in Dysport’s 2025 revenues between the two fields, respectively.
First approved by the FDA in 2009 for cervical dystonia and glabellar lines, Dysport is also indicated for certain patients with spasticity.
Migraine, including both episodic and chronic forms, affects around 14% to 15% of the global population. Coming at both forms of the disease from another angle, Ipsen is advancing a recombinant neurotoxin called corabotase (IPN10200) in phase 2, while having already moved the asset into phase 3 in aesthetics.
In the phase 2 Lantic study in aesthetics, corabotase offered a significantly longer duration of effect versus Dysport in terms of achieving a score of “none” or “mild” line severity at week 24, Ipsen reported in September 2025.
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The newer molecule was also embroiled in a dispute between Ipsen and its long-time commercialization partner Galderma. The two companies had previously clashed over the control of next-generation neuromodulator projects as Ipsen moved to terminate their R&D partnership signed in 2014.
In a final decision issued in January 2026, the arbitral tribunal of the International Chamber of Commerce sided with Ipsen, allowing the French pharma to terminate the R&D agreement and take full control of its clinical-stage toxin programs in the aesthetic field. The R&D legal brouhaha didn’t affect the two companies’ commercialization collaboration around Dysport.