Dysport® is the first botulinum toxin to achieve positive topline Phase III results in both episodic and chronic migraine.
Summary by AI BETAClose X
- Dysport® achieved statistically significant topline Phase III results, meeting primary endpoints in both episodic (E-BEOND) and chronic (C-BEOND) migraine
- Dysport is the first botulinum toxin in episodic migraine to demonstrate a statistically significant reduction in monthly migraine days
- Dysport was well-tolerated across both trials with safety consistent with the known profile
PARIS, FRANCE – 9 JULY 2026 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced positive topline results from its Phase III BEOND migraine program evaluating Dysport® (abobotulinumtoxinA) for the prevention of episodic (E-BEOND) and chronic migraine (C-BEOND) in adults. Both the E-BEOND and C-BEOND trials met their primary endpoints, a reduction in monthly migraine days versus placebo.
The E-BEOND results represent the first Phase III trial in which a botulinum toxin has demonstrated statistically significant efficacy in episodic migraine. Together with the positive C-BEOND results, BEOND is the first Phase III clinical program to demonstrate efficacy of a botulinum toxin in the prevention of both episodic and chronic migraine.
Dysport was well-tolerated. Safety findings observed across both trials were consistent with well-established use of Dysport in approved indications, with no new or unexpected signals identified.
"These results represent a significant advance in the development of botulinum toxin therapies for migraine," said Christelle Huguet, PhD, EVP and Global Head of R&D. "BEOND is the first Phase III program to demonstrate efficacy of a botulinum toxin in both episodic and chronic migraine. Together, these findings position Dysport as a potential first-in-class treatment for a broad migraine population."
Migraine remains a common neurological disorder with a high unmet medical need. Migraine can be severely debilitating for people living with the condition and may have life-long impacts, frequently disrupting their ability to work, to plan or enjoy a social life. Episodic migraine (defined in the E-BEOND trial as experiencing up to 14 headache days per month of which at least 6 were migraine days) is a substantially larger patient population than chronic migraine (defined as experiencing headaches on 15 or more days per month, with at least 8 migraine days).
“These Phase III topline results position Dysport as the first botulinum toxin to demonstrate efficacy for both episodic and chronic migraine prevention, supporting an advance in treatment options for patients,” said Dr. Cristina Tassorelli, MD, Professor and Chair of Neurology and Director of the Department of Brain and Behavioral Sciences at the University of Pavia, based in Pavia, Italy and Principal Investigator for the C-BEOND trial.
"Preventive treatment options for episodic migraine remain limited. These clinical trial results are encouraging because they suggest a potential new preventative therapy that, if approved, may benefit a broad group of patients,” said Dr. Jessica Ailani MD, Clinical Professor of neurology at MedStar's Georgetown University Hospital and Director of the MedStar Georgetown Headache Center, based near Washington DC, and Principal Investigator for the E-BEOND trial.
Detailed findings from the BEOND program will be presented at a future scientific congress.
About the DYSPORT BEOND PHASE III migraine program
The BEOND Phase III program included two randomized, multi-center, placebo-controlled trials, C-BEOND (NCT06047444) and E-BEOND (NCT06047457). The trials enrolled 1,510 patients across 120 centers. The primary endpoint for both trials was the change from baseline in the number of monthly migraine days at week 24 (measured over weeks 21 to 24). The Extension Phase of the BEOND trials, where all participants receive Dysport for two treatment cycles, will continue to week 48.
About Migraine
Migraine is a complex neurological disease characterized by recurrent attacks of headache and migraine, and is estimated to impact approximately 14% of the world’s population1. People living with migraine experience symptoms that include recurring throbbing headache pain, nausea, vomiting, and sensitivity to light, sound, touch and smell. These symptoms can have a life-long impact on the person as well as their families. Migraine can be categorized as episodic migraine or chronic migraine. People living with chronic migraine experience 15 or more headache days per month, of which at least 8 are migraine days. People living with episodic migraine can experience up to 14 headache days per month of which at least 6 are migraine days (as defined in the E-BEOND trial).
About Dysport
Dysport® (abobotulinumtoxinA) is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which is a substance derived from Clostridium bacteria producing BoNT-A that inhibits the effective transmission of nerve impulses and thereby reduces muscular contractions. It is supplied as a lyophilized powder. AbobotulinumtoxinA has marketing authorization in approximately 90 countries, more than 30 years of clinical experience and >21 million treatment years of patient experience.
The detailed recommendations for the use of Dysport® are described in the Summary of Product Characteristics (SmPC) and the U.S. Prescribing Information (PI) for Dysport (300 units) Powder and Dysport (500 units) Powder.
NOTE: Dysport® labels and approved indications may vary from country to country.
About Ipsen
We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries.
Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.
| Ipsen Contacts | ||
| Investors | ||
| Henry Wheeler | henry.wheeler@ipsen.com | +33 7 66 47 11 49 |
| Khalid Deojee | khalid.deojee@ipsen.com | +33 6 66 01 95 26 |
| Media | ||
| Sally Bain | sally.bain@ipsen.com | +1 857 320 0517 |
| Anne Liontas | anne.liontas.ext@ipsen.com | +33 7 67 34 72 96 |
Disclaimers and/or forward-looking statements
The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation and risks arising from unexpected regulatory or political changes such as changes in tax regulation and regulations on trade and tariffs, such as protectionist measures, especially in the United States; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com.
Attachment
Latest directors dealings
- 2 days ago Close Brothers Group
- 2 days ago Savannah Energy
- 2 days ago Mid Wynd International Inv Trust
- 2 days ago Dillistone Group
- 2 days ago SSP Group