2024 Approvals

Letybo Approved as a New Therapy for Moderate to Severe Glabellar Lines

Jasmine C

05 Dec 2025 — 1 min read

SMHAP01 (4)

What is it prescribed for?

LETYBO approved on February 29, 2024, is indicated to treat moderate-to-severe frown lines in adults.

What is the name of the drug and what does it do?

Letybo (pronounced leh-TEE-boh), (generic name: letibotulinumtoxinA-wlbg), is a medication indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) associated with corrugator and/or procerus muscle activity in adult patients.

How does it work?

Letybo is an acetylcholine release inhibitor and a neuromuscular blocking agent.

It works by blocking the release of acetylcholine, a neurotransmitter responsible for muscle contraction.

By inhibiting acetylcholine release, Letybo causes temporary muscle paralysis in the treated area, which helps to reduce the appearance of glabellar lines.

What did the research discover?

Clinical trials, including the BLESS I, BLESS II, and BLESS III studies, have demonstrated that Letybo is effective in reducing the appearance of glabellar lines.

In these studies, a significant percentage of patients treated with Letybo achieved a marked improvement in the severity of their glabellar lines compared to those treated with a placebo.

The studies showed that Letybo had a favorable safety profile, with most adverse reactions being mild to moderate in severity.

What are some of the side effects?

Common side effects of Letybo include:

Headache
Brow ptosis (drooping of the eyebrow)
Eyelid ptosis (drooping of the eyelid)
Blepharospasm (involuntary eye twitching)
Injection site reactions (e.g., swelling, bruising, pain)

What are the dosage recommendations and how is it prescribed?

The recommended dose of Letybo is 0.1 mL (4 Units) administered by intramuscular injection into each of five sites for a total dose of 20 Units.

The injections should be evenly distributed among the corrugator and procerus muscles. Letybo should be administered no more frequently than every three months, and proper reconstitution and administration techniques should be followed to ensure safety and effectiveness.

Source:

Hugel, Inc. Letybo (letibotulinumtoxinA-wlbg) for injection, for intramuscular use. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761225s000lbl.pdf

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