Ipsen’s IPN10200 Demonstrates Long-Lasting Efficacy in Phase II LANTIC Trial for Glabellar Lines

Ipsen has shared positive results from its first aesthetic data readout of the Phase II LANTIC clinical trial (NCT04821089) investigating internally developed IPN10200 for the treatment of glabellar lines.¹

Statistically significant improvement versus placebo

Following Stage 1 of the multi-stage, ongoing LANTIC study, patients treated with IPN10200 showed a statistically significant improvement in response at week 4 versus placebo, meeting the primary endpoint. Further, the first-in-class recombinant molecule continued to demonstrate a greater response in line severity versus Dysport at week 36.

In a press release, David Loew, CEO of Ipsen, said: “The data demonstrates that we have a first-in-class, unique molecule with the potential to be a breakthrough innovation in aesthetics, demonstrating truly longer duration versus an established botulinum A for glabellar lines. Today’s announcement is an important milestone for Ipsen as we advance our pipeline and underscores our commitment and expertise, built on a more than 30-year legacy in neuroscience.”

Long duration of effect and favorable safety profile

Additional data from this latest readout of LANTIC show:

• IPN10200 achieved a statistically significant improvement versus placebo for the primary endpoint, defined as a 2-grade improvement on both investigator and patient assessments of line severity at week 4, consistent with the peak effect seen with Dysport.
• A longer duration of effect was observed, with most patients showing a clinically meaningful response (rated “none” or “mild” by investigator assessment) at week 24 compared with placebo and Dysport.
• Patient diary data indicated rapid onset of action with IPN10200.
• The treatment was well tolerated, with no safety concerns reported across the evaluated doses in Stage 1.

Ipsen plans to share more glabellar line data from this study at a scientific conference in the first half of 2026. The company has already begun activities to set up its Phase III program for further research in glabellar lines.

In the press release, Christelle Huguet, PhD, EVP and Head of R&D, Ipsen, added: “IPN10200’s novel design, derived from active sequence part A and binding sequence part B, is optimized for safety and efficacy. Uniquely engineered to deliver increased receptor affinity and internalization IPN10200 has shown this clinically significant long duration of effect, experienced for the first time by a substantial majority of patients at week 24. These data are reinforced by the rapid onset of action and superior patient satisfaction scores versus placebo and versus Dysport. We are committed to advancing science with purpose to bring the benefits patients are looking for, as we believe everyone deserves a life fully lived.”

Trial design of the LANTIC program

As mentioned earlier, LANTIC is ongoing. Ipsen is currently enrolling for Stage 2 which will evaluate the efficacy and safety of IPN10200 compared with placebo in forehead lines or lateral canthal lines.

• The study is structured in three stages. Stage 1 focused on glabellar lines through three steps: Phase Ib dose escalation, Phase II dose finding versus placebo and Dysport, and an additional Phase II dose-finding study versus placebo and Dysport.
• Different dose levels of IPN10200 were tested across each step. Step 3, with 183 patients, provided proof-of-concept data for glabellar lines.
• Stages 2 and 3 (Phase II) are designed to evaluate IPN10200 across all three upper facial line indications compared to placebo.

Additional Phase II studies under way

Outside of LANTIC, IPN10200 is being evaluated across three other Phase II studies:

• CATALPA (NCT06937931): A multicenter, randomized, double-blind, parallel-group, placebo-controlled study in adult cervical dystonia participants.²
• MERANTI (NCT06625060): A multicenter, randomized, double-blind, placebo-controlled, dose escalation and dose finding study in episodic or chronic migraine prevention in adults.³
• LANTIMA (NCT04752774): An integrated multicenter, double-blind, randomized, Dysport and placebo-controlled, dose escalation and dose-finding in adult upper limb spasticity.⁴

References

1. Ipsen’s LANTIC Phase II in aesthetics delivers a first-in-class, differentiated long-acting clinical profile for IPN10200, enabling the initiation of Phase III. News release. Ipsen. September 22, 2025. Accessed September 22, 2025. https://www.ipsen.com/press-releases/ipsens-lantic-phase-ii-in-aesthetics-delivers-a-first-in-class-differentiated-long-acting-clinical-profile-for-ipn10200-enabling-the-initiation-of-phase-iii-3153621/

2. A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults (CATALPA). ClinicalTrials.gov. Updated August 28, 2025. Accessed September 22, 2025. https://clinicaltrials.gov/study/NCT06937931?intr=IPN10200&rank=1

3. A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults (MERANTI). ClinicalTrials.gov. Updated August 28, 2025. Accessed September 22, 2025. https://clinicaltrials.gov/study/NCT06625060?intr=IPN10200&rank=2

4. A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity. (LANTIMA). ClinicalTrials.gov. Updated August 27, 2025. Accessed September 22, 2025. https://clinicaltrials.gov/study/NCT04752774?intr=IPN10200&rank=3