Ipsen Pharmaceuticals’ Dysport (abobotulinumtoxinA), a Botox (onabotulinumtoxinA) competitor, could be on track for a label expansion after the drug posted a double Phase III win in two migraine indications.
Within a duo of late-stage studies, which include the E-BEOND (NCT06047457) and C-BEOND (NCT06047444) trials focused on episodic and chronic migraine, respectively, Dysport significantly reduced the number of monthly migraine days versus placebo – meeting the primary endpoint of both studies.
Patients also tolerated Dysport well in both trials, with no new or unexpected safety signals identified through its use in the BEOND programme. Both were randomised, double blind, placebo controlled clinical studies.
The topline outcomes of these Phase III studies see Dysport become the first botulinum toxin-based therapy to surpass the significant efficacy milestone in episodic migraine, Ipsen says. This potentially positions it to become a “new preventative therapy that, if approved, may benefit a broad group of patients”, noted E-BEOND principal investigator and Georgetown University Hospital clinical neurology professor, Dr Jessica Ailani.
Dysport’s potential approval in migraine would also notch some more indications to the drug’s belt, as it is currently greenlit by the US Food and Drug Administration (FDA) for treating involuntary neck muscle contraction condition, cervical dystonia, as well as upper and lower limb spasticity and glabellar lines.
Expanding Dysport’s role as a therapeutic
Dysport’s early Phase III success comes as preventive treatments for episodic migraine – which impacts nine in ten patients with the condition – remain limited, and unmet needs still pose significant challenges in clinical care. While definitions range in what classifies as an ‘episodic’ migraine, Ipsen consider it to be patients who experienced 14 or fewer headache days and six or fewer migraine days within the E-BEOND trial.
According to Ipsen’s EVP and global R&D head, Christelle Huguet, the BEOND findings could position Dysport as a “potential first-in-class treatment” on the migraine market currently dominated by AbbVie’s Botox, which regulators have approved for patients with a chronic, not episodic, form of the condition.
Dysport and Botox are both injectable neurotoxins that use a form of botulinum toxin type A. During a migraine, sensory nerves around the head and neck transmit signals that result in severe pain and sensitivity. When injected under the skin and into the muscles, the medication targets nerve endings and inhibits the release of chemicals and neuropeptides that calm the sensory nerves.
Botox generated $3.76bn in net revenues on the therapeutic market in 2025, while Ipsen’s rival drug brought in €297m ($340m) in its approved indications.
Ipsen is also betting on the potential of its novel, recombinant neuroinhibitor, corabotase, which is currently in the Phase II MERANTI trial (NCT06625060) for migraine. Ipsen says it has intentionally optimised corabotase to enhance uptake, resist degradation and boost its receptor affinity. Recently, the drug posted positive results in a mid-stage study in glabellar lines, as patients reported sustained duration of effect and high satisfaction with the treatment.
