botulinum toxin A longer acting (IPN10200) / Ipsen - LARVOL DELTA

LANTIC: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines (clinicaltrials.gov) - P1/2 | N=727 | Recruiting | Sponsor: Ipsen | Trial primary completion date: Mar 2026 ➔ Aug 2026

Trial primary completion date

Ipsen…announced the first aesthetic data (n=183) for glabellar lines with internally developed IPN10200, following Stage 1 of the multi-stage, ongoing Phase II LANTIC trial. (The Manila Times) - "Patients treated with IPN10200 showed a statistically significant improvement in response at Week 4 vs placebo (primary endpoint). A longer duration of effect was also observed with a substantial majority of patients experiencing a clinically significant response at Week 24 compared with placebo and Dysport, defined as a score of "none” or "mild”. IPN10200 continued to show a greater response in line severity vs Dysport at Week 36. In this trial Dysport was shown to perform consistently with its profile."

P2 data • Dermatology

CATALPA: A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults (clinicaltrials.gov) - P2 | N=132 | Recruiting | Sponsor: Ipsen | Trial primary completion date: Feb 2026 ➔ Mar 2027

Trial primary completion date • CNS Disorders • Dystonia • Movement Disorders

LANTIMA: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity. (clinicaltrials.gov) - P1/2 | N=240 | Recruiting | Sponsor: Ipsen | Active, not recruiting ➔ Recruiting

Enrollment open • Movement Disorders

CATALPA: A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults (clinicaltrials.gov) - P2 | N=132 | Recruiting | Sponsor: Ipsen | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Dystonia • Movement Disorders

Ipsen delivers strong results in the first half of 2025 and upgrades its full-year guidance (GlobeNewswire) - "H1 total sales growth of 11.4% at CER, or 9.7% as reported, driven by the three therapeutic areas: 95.7% in Rare Disease, 9.7% in Neuroscience, and 6.4% in Oncology; H1 core operating income of €656m, growing by 21.9% as reported, with a core operating margin of 36.0% of total sales, increasing by 3.6 points; Upgraded FY 2025 financial guidance: total-sales growth greater than 7.0% at CER (prior guidance: greater than 5.0% at CER); core operating margin greater than 32.0% of total sales (prior guidance: greater than 30%)"

Commercial • Dystonia • Neuroendocrine Tumor • Primary Biliary Cholangitis • Renal Cell Carcinoma

CATALPA: A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults (clinicaltrials.gov) - P2 | N=132 | Not yet recruiting | Sponsor: Ipsen

New P2 trial • CNS Disorders • Dystonia • Movement Disorders

MERANTI: A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults (clinicaltrials.gov) - P2 | N=641 | Recruiting | Sponsor: Ipsen | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Migraine • Pain

MERANTI: A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults (clinicaltrials.gov) - P2 | N=641 | Not yet recruiting | Sponsor: Ipsen

New P2 trial • CNS Disorders • Migraine • Pain

LANTIMA: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity. (clinicaltrials.gov) - P1/2 | N=240 | Active, not recruiting | Sponsor: Ipsen | Trial completion date: Jun 2026 ➔ Oct 2027 | Trial primary completion date: Sep 2024 ➔ Oct 2027

Trial completion date • Trial primary completion date • Movement Disorders

LANTIC: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines (clinicaltrials.gov) - P1/2 | N=727 | Recruiting | Sponsor: Ipsen | Trial primary completion date: Nov 2024 ➔ Mar 2026

Trial primary completion date

LANTIMA: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity. (clinicaltrials.gov) - P1/2 | N=209 | Active, not recruiting | Sponsor: Ipsen | Recruiting ➔ Active, not recruiting

Enrollment closed • Movement Disorders

LANTIC: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines (clinicaltrials.gov) - P1/2 | N=727 | Recruiting | Sponsor: Ipsen | Active, not recruiting ➔ Recruiting

Enrollment open

LANTIC: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines (clinicaltrials.gov) - P1/2 | N=727 | Active, not recruiting | Sponsor: Ipsen | N=547 ➔ 727 | Trial primary completion date: Apr 2023 ➔ Nov 2024

Enrollment change • Trial primary completion date

LANTIMA: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity. (clinicaltrials.gov) - P1/2 | N=209 | Recruiting | Sponsor: Ipsen | Trial completion date: Sep 2024 ➔ Jun 2026

Trial completion date • Movement Disorders

LANTIC: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines (clinicaltrials.gov) - P1/2 | N=547 | Active, not recruiting | Sponsor: Ipsen | N=191 ➔ 547 | Trial completion date: Dec 2024 ➔ Mar 2027

Enrollment change • Trial completion date

LANTIC: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines (clinicaltrials.gov) - P1/2 | N=191 | Active, not recruiting | Sponsor: Ipsen | Completed ➔ Active, not recruiting

Enrollment closed

LANTIC: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines (clinicaltrials.gov) - P1/2 | N=191 | Completed | Sponsor: Ipsen | Active, not recruiting ➔ Completed

Trial completion

LANTIMA: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity. (clinicaltrials.gov) - P1/2 | N=209 | Recruiting | Sponsor: Ipsen | Trial completion date: Mar 2024 ➔ Sep 2024 | Trial primary completion date: Mar 2024 ➔ Sep 2024

Trial completion date • Trial primary completion date • Movement Disorders

LANTIC: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines (clinicaltrials.gov) - P1/2 | N=191 | Active, not recruiting | Sponsor: Ipsen | Recruiting ➔ Active, not recruiting | N=547 ➔ 191

Enrollment change • Enrollment closed

LANTIC: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines (clinicaltrials.gov) - P1/2 | N=547 | Recruiting | Sponsor: Ipsen | N=110 ➔ 547

Enrollment change

LANTIC: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: Ipsen | Active, not recruiting ➔ Recruiting | N=80 ➔ 110

Enrollment change • Enrollment open

LANTIC: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines (clinicaltrials.gov) - P1/2 | N=80 | Active, not recruiting | Sponsor: Ipsen | Recruiting ➔ Active, not recruiting

Enrollment closed

LANTIC: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: Ipsen | N=80 ➔ 110 | Trial completion date: Apr 2023 ➔ Oct 2023 | Trial primary completion date: Aug 2022 ➔ Feb 2023

Enrollment change • Trial completion date • Trial primary completion date

LANTIC: A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Ipsen | N=56 ➔ 80 | Trial completion date: Nov 2022 ➔ Apr 2023 | Trial primary completion date: Mar 2022 ➔ Aug 2022

Enrollment change • Trial completion date • Trial primary completion date