Leqembi Iqlik (lecanemab-irmb subcutaneous) / Biogen, BioArctic, Eisai - LARVOL DELTA

Clarity AD: A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P3 | N=1906 | Active, not recruiting | Sponsor: Eisai Inc. | Trial completion date: May 2027 ➔ Jun 2029 | Trial primary completion date: May 2027 ➔ Jun 2029

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Clarity AD: A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P3 | N=1906 | Active, not recruiting | Sponsor: Eisai Inc. | Trial completion date: Jun 2029 ➔ Dec 2026 | Trial primary completion date: Jun 2029 ➔ Dec 2026

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Clarity AD: A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P3 | N=1906 | Active, not recruiting | Sponsor: Eisai Inc. | Trial completion date: Sep 2027 ➔ May 2027 | Trial primary completion date: Sep 2027 ➔ May 2027

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Clarity AD: A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P3 | N=1906 | Active, not recruiting | Sponsor: Eisai Inc. | Trial completion date: Sep 2025 ➔ Sep 2027 | Trial primary completion date: Sep 2025 ➔ Sep 2027

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Clarity AD: A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P3 | N=1906 | Active, not recruiting | Sponsor: Eisai Inc. | Trial completion date: Aug 2024 ➔ Sep 2025 | Trial primary completion date: Sep 2022 ➔ Sep 2025

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Clarity AD: A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P3 | N=1566 | Recruiting | Sponsor: Eisai Inc. | Trial primary completion date: Mar 2024 ➔ Feb 2022

Trial primary completion date • Alzheimer's Disease • CNS Disorders

Clarity AD: A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P3 | N=1566 | Recruiting | Sponsor: Eisai Inc. | Trial primary completion date: Feb 2022 ➔ Jun 2022

Trial primary completion date • Alzheimer's Disease • CNS Disorders

Clarity AD: A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P3 | N=1766 | Active, not recruiting | Sponsor: Eisai Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders

Clarity AD: A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P3 | N=1566 | Recruiting | Sponsor: Eisai Inc. | Trial completion date: Mar 2024 ➔ Jul 2024

Trial completion date • Alzheimer's Disease • CNS Disorders

Clarity AD: A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P3 | N=1556 | Recruiting | Sponsor: Eisai Inc.

New P3 trial • Alzheimer's Disease • CNS Disorders

Eisai Co., Ltd. and Biogen…announced today that 'LEQEMBI Pen', the subcutaneous (SC) formulation of the anti-amyloid beta (Aβ) protofibril antibody 'LEQEMBI' (brand name, generic name: lecanemab) has been approved in Japan as a new route of administration (GlobeNewswire) - "LEQEMBI Pen is an autoinjector formulation that enables administration by a care partner or patient self-administration, with two pens (totaling 500 mg) administered once weekly....This approval is based on the integrated results of data and associated modeling and simulation from the 18-month core study of the Phase 3 Clarity AD study of LEQEMBI in patients with mild cognitive impairment (MCI) due to AD or mild AD dementia (collectively referred to as early AD), as well as multiple SC administration sub-studies in its subsequent long-term extension study (LTE)."

Japan approval • Alzheimer's Disease

In brief: Subcutaneous lecanemab (Leqembi Iqlik) for initial treatment of Alzheimer’s disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders

LEQEMBI (lecanemab) Subcutaneous Formulation as an Initiation Treatment for Early Alzheimer’s Disease Approved in China (Eisai Press Release) - "The application was accepted by the NMPA in January 2026 and was subsequently granted Priority Review designation...Launch is planned during Eisai’s FY 2026, ending March 31, 2027...This approval is based on the integrated results of data and associated modeling and simulation from the 18-month core study of the Phase 3 Clarity AD study of LEQEMBI in patients with early AD, as well as multiple subcutaneous (SC) administration substudies (including the Chinese cohort) in its subsequent long-term extension (LTE)."

China approval • Launch non-US • Alzheimer's Disease

FDA Approves First At-home Starting Dose for Alzheimer’s Disease Treatment (FDA) - "The effectiveness of Leqembi was tested in....Study 2 NCT03887455) in patients with Alzheimer’s disease (patients with confirmed presence of amyloid pathology and mild cognitive impairment or mild dementia stage of disease)."

FDA approval • Alzheimer's Disease

Eisai Co., Ltd. and Biogen…announced today that once weekly lecanemab-irmb subcutaneous injection (brand name: LEQEMBI IQLIK) is now available in the U.S. for initiation therapy for early Alzheimer’s disease (AD) in adults with mild cognitive impairment (MCI) or mild dementia due to AD, collectively referred to as early AD (GlobeNewswire) - "LEQEMBI IQLIK is administered via an autoinjector, introducing a convenient alternative to intravenous (IV) dosing from the start of treatment. For initiation, the approved regimen is 500 mg given once weekly as two consecutive 250 mg injections, each delivered in approximately 15 seconds. LEQEMBI IQLIK may also be used for maintenance dosing at 360 mg once weekly after 18 months of IV or subcutaneous (SC) treatment....Eisai’s Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost, for eligible uninsured patients, who meet financial need and other program criteria."

Launch US • Reimbursement • Alzheimer's Disease

LEQEMBI Subcutaneous Autoinjector Clinical Data Supports Similar Efficacy and Safety to IV Formulation in Early Alzheimer’s Disease Presented at the Alzheimer’s Association International Conference (AAIC) 2026 (GlobeNewswire) - "500 mg SC-AI demonstrated bioequivalence to the IV initiation regimen (10 mg/kg every two weeks), with an exposure ratio of 104% (90% confidence interval [CI]: 99.1%–109%)....Amyloid removal measured by amyloid PET, clinical efficacy measured by CDR-SB, and the incidence of ARIA-E were driven by lecanemab exposure rather than route of administration. The 500 mg SC-AI initiation regimen achieved exposure comparable to the IV initiation regimen, supporting the expectation of a comparable efficacy and safety profile despite the different route of administration....The 500 mg SC-AI initiation regimen demonstrated consistent exposure, amyloid clearance as measured by amyloid PET, clinical efficacy and safety across body weight groups."

Clinical data • Alzheimer's Disease