LETYBO®

What Is LETYBO®? LetibotulinumtoxinA by Hugel

LETYBO® is an injectable neuromodulator manufactured by Hugel Inc., a South Korean pharmaceutical company specializing in aesthetic and therapeutic botulinum toxin products. Its active ingredient, letibotulinumtoxinA, is a highly purified botulinum toxin type A that temporarily blocks the release of acetylcholine at the neuromuscular junction. This interruption in nerve signaling reduces targeted muscle activity, producing the temporary muscle relaxation that practitioners associate with botulinum toxin treatments. As a LETYBO® neurotoxin, it sits within the broader category of injectable neuromodulators used in aesthetic medicine.

A key regulatory milestone for LETYBO® was its 2024 FDA approval for the temporary improvement of moderate to severe glabellar lines in adults, making it the first letibotulinumtoxinA product to receive this approval [3].

LETYBO® and BOTULAX® are both manufactured by Hugel Inc. and contain the same active substance, letibotulinumtoxinA, produced from the same manufacturing strain (CBFC26). BOTULAX® is the trade name used internationally, while LETYBO® is the brand registered with the US FDA and European authorities. The critical difference is regulatory: only LETYBO® has received FDA approval. LETYBO® is also CE-marked for use in European markets.

The product is supplied as a lyophilized powder in single-dose 50-unit (LETYBO® 50UI) and 100-unit vials and must be reconstituted with sterile saline before administration by a qualified healthcare professional.

LETYBO® FDA Approval and Regulatory Status

FDA approval covers moderate to severe glabellar lines in adults, and it stands as the product’s primary clinical and commercial differentiator in the US market. LETYBO® FDA approval rested on a Biologics License Application supported by an extensive Phase III program, enrolling more than a thousand patients across multiple trials, with responder rate data and an efficacy and safety profile that met FDA review standards [1][3].

Regulatory status by market:

• FDA-approved in the United States (2024)
• CE-marked for the EU and UK
• MFDS-approved in South Korea
• Prescription-only in all approved markets

The distinction between LETYBO® and BOTULAX® is important to understand for practitioners researching Hugel’s product portfolio. Both are manufactured by Hugel Inc. and share the same active substance, letibotulinumtoxinA, from the same CBFC26 strain, but they are registered under different trade names with different regulatory standing.

Only LETYBO® has received FDA approval for the temporary improvement of moderate to severe glabellar lines in adults. BOTULAX® has not received FDA approval. Healthcare professionals looking to purchase LETYBO® online should verify they are ordering the intended Hugel product based on its brand name, labeling, and regulatory status for their market.

Dosage, Administration, and Storage

The approved dosage for glabellar lines is 20 units, injected across 5 points in the glabellar muscle complex [4]. On the LETYBO® vs Botox unit equivalence question, a head-to-head trial comparing the CBFC26-strain toxin that later became LETYBO® against onabotulinumtoxinA found that 20 units performed comparably to 20 units of onabotulinumtoxinA for glabellar lines, with response rates of 89.3% versus 81.9% at week 4 [2]. This trial predates LETYBO®’s FDA approval by roughly a decade and was conducted in South Korea under the molecule’s earlier development name, rather than as part of the US registration package itself.

Onset falls in the hours to weeks range typical of the BTX-A class, generally 3 to 7 days, with full effect visible at 10 to 14 days. Duration runs 3 to 4 months for glabellar lines. For storage, practitioners should store unopened vials at 2°C to 8°C and never freeze [4]. Once reconstituted, use within 24 hours and refrigerate the product between uses.

Treatment Areas and Indications

The FDA-approved indication is specific: moderate to severe glabellar lines, or frown lines, in adults. That is the primary approved use in the US market. Any candidate for LETYBO® treatments should present with moderate to severe dynamic glabellar lines and have aesthetic goals consistent with temporary muscle relaxation in the glabellar complex. CE marking extends further in some respects, covering glabellar lines plus additional aesthetic upper face indications under EU labeling, such as forehead lines and crow’s feet, though availability varies by market and should be verified against local product IFU.

As with any BTX-A product, off-label use in other facial aesthetic and therapeutic contexts occurs based on practitioner clinical judgment, though the FDA-reviewed indication remains specifically glabellar line reduction. LETYBO® injections follow the same standard BTX-A injection technique practitioners already use for the glabellar complex with other neuromodulators. Published LETYBO® before and after data from clinical trials shows visible improvement in glabellar line severity at rest and at maximum frown, with onset and duration comparable to other BTX-A products in the same class.

Full LETYBO® Product Range

The LETYBO® manufacturer, Hugel Inc., supplies LETYBO® as a single letibotulinumtoxinA formulation in two lyophilized, single-dose vial presentations requiring reconstitution before administration. Practitioners evaluating LETYBO® cost and pricing should note that both vial sizes are available, and clinics that buy LETYBO® wholesale may be able to manage per-unit LETYBO® price more effectively depending on treatment volume and clinical workflow.

• LETYBO® 50 Units: A 50-unit single-dose vial supplied as a lyophilized powder for reconstitution. This is the standard LETYBO® presentation for individual treatment sessions and the strength most commonly referenced in clinical trial protocols for the glabellar indication [4].
• LETYBO® 100 Units: A 100-unit single-dose vial containing the same letibotulinumtoxinA formulation in a larger presentation. This vial size is suited to practices with higher patient volumes or those performing multiple treatment sessions within the recommended period after reconstitution.

Both vial sizes are reconstituted using the same principles, with dilution adjusted according to vial size.

LETYBO® Compared to Other Botulinum Toxin Products

LETYBO® vs BOTULAX®

LETYBO® and BOTULAX® are both manufactured by Hugel Inc. in South Korea and share the same INN, letibotulinumtoxinA, produced from the same CBFC26 strain. BOTULAX® is the trade name used in international markets outside the US, while LETYBO® is the brand name registered with the US FDA and European regulatory authorities. The primary distinction between them is regulatory standing, not molecular. LETYBO® received FDA approval in 2024 for the temporary improvement of moderate to severe glabellar lines following a formal Phase III clinical development program, whereas BOTULAX® remains a CE-marked product without FDA approval in the United States.

LETYBO® also demonstrated clinical equivalence to 20 units of BOTOX® for glabellar lines during a head-to-head comparison trial [2]. While BOTULAX® is commonly used at comparable doses in clinical practice, it does not have the same FDA-validated equivalence data. For practitioners, the distinction lies primarily in regulatory status, clinical evidence, and the depth of supporting data available for each product.

LETYBO® vs NABOTA®

NABOTA® (prabotulinumtoxinA) is manufactured by Daewoong and marketed in the United States as Jeuveau®, giving it a regulatory position comparable to LETYBO® because both are FDA-approved Korean botox type A products indicated for moderate to severe glabellar lines. Clinical studies position NABOTA®/Jeuveau® as 1:1 with BOTOX®, while LETYBO® demonstrated comparable efficacy to 20 units of BOTOX® in its own Phase III clinical program [2].

The products differ in both manufacturer and active ingredient, with LETYBO® containing letibotulinumtoxinA and NABOTA® containing prabotulinumtoxinA. Both require refrigerated storage before reconstitution, so selection often depends on pricing, formulary preferences, distributor relationships, and product availability rather than a clearly demonstrated clinical advantage.

LETYBO® vs INNOTOX®

INNOTOX® is the most distinct product in this comparison because it is the only commercially available ready-to-use liquid botulinum toxin type A formulation, eliminating the need for reconstitution before injection. LETYBO®, by contrast, is supplied as a lyophilized powder containing letibotulinumtoxinA and must be reconstituted with sterile saline before administration. INNOTOX® (Medytox) is classified as a botulinum toxin type A derived from the Clostridium botulinum Hall strain but does not carry a unique INN or USAN, distinguishing it from products like LETYBO® (letibotulinumtoxinA) or XEOMIN® (incobotulinumtoxinA) that have formally assigned nonproprietary names.

INNOTOX® is CE-marked in applicable markets but has not received FDA approval for aesthetic use, whereas LETYBO® is FDA-approved for glabellar lines. The liquid presentation of INNOTOX® offers a practical workflow advantage for clinics that prioritize preparation time, while LETYBO®’s FDA approval provides a regulatory advantage for practitioners who need an FDA-reviewed botulinum toxin product.

LETYBO® vs XEOMIN®

XEOMIN® (incobotulinumtoxinA, Merz, Germany) stands out in this lineup for one specific reason: it is a “naked” toxin, meaning the complexing proteins present in most other BTX-A formulations, LETYBO® included, have been stripped out during manufacturing. The theory behind this is a lower long-term immunogenicity risk, though that remains a theoretical benefit rather than something demonstrated in a direct trial against LETYBO®. XEOMIN® also does not need refrigeration before reconstitution and can be stored at room temperature up to 25°C, which is a meaningful logistical edge over a product that has to stay cold from manufacturer to injection.

Regulatory status is where these two are most closely aligned: both are FDA-approved and CE-marked. Where they diverge is track record. XEOMIN® has been on the FDA-approved market considerably longer and carries a deeper body of Western clinical data behind it. LETYBO® is the newer arrival, bringing Korean manufacturing origin into a category that has historically been led by European and American brands.

LETYBO® vs BOCOUTURE®

Both are Merz brands for incobotulinumtoxinA, with BOCOUTURE® marketed in European and UK aesthetic markets and XEOMIN® used in other regions. Each features the same highly purified formulation without complexing proteins. Under CE marking, BOCOUTURE® is approved for the temporary improvement of glabellar lines, crow’s feet, and forehead lines.

LETYBO® also holds CE marking for aesthetic use and additionally has FDA approval in the United States. In comparison, BOCOUTURE® benefits from a longer clinical track record and more established use across the markets where both products are available. Another practical difference is storage: BOCOUTURE® can be stored at room temperature before reconstitution, whereas LETYBO® requires refrigerated storage throughout its shelf life.

Clinical Benefits and Safety

LETYBO®’s FDA approval represents its most significant clinical milestone, reflecting an established safety profile validated in extensive clinical trials [1][3]. As the only FDA-approved botulinum toxin product in Hugel’s portfolio, it holds the strongest regulatory credential among the company’s BTX-A products. Clinical data demonstrated responder rates for moderate to severe glabellar lines comparable to those achieved with 20-unit BOTOX®, positioning LETYBO® as a credible Botox alternative supported by robust clinical evidence rather than marketing claims alone [1][2].

However, deciding if one is better than the other cannot be easily determined. We see in clinical practice discussions, and in the published trial data, that current evidence does not demonstrate a clinically meaningful difference in treatment duration between LETYBO® and BOTOX®. Phase III studies indicate that LETYBO® provides efficacy and duration comparable to BOTOX® when used at their recommended doses for glabellar lines [1].

Common LETYBO® side effects are consistent with those observed across other botulinum toxin type A products and are generally mild, transient, and self-limiting [1]. Some LETYBO® reviews commonly reference adverse events such as:

• Injection-site bruising
• Mild headache
• Temporary swelling at the injection site
• Eyelid ptosis, a recognized upper-face treatment risk that is primarily related to injection technique and anatomical considerations

Published clinical studies and post-approval experience continue to support LETYBO®’s favorable safety profile, with most adverse events resolving without intervention and occurring at rates comparable to other established botulinum toxin products [1][5]. LETYBO® reviews from practitioners have generally reflected the efficacy and tolerability reported in clinical trials, reinforcing its position as a reliable treatment option for glabellar lines [5].

Where to Buy LETYBO® Online

LETYBO® is a prescription pharmaceutical, available only to licensed medical professionals through authorized distributors. For practitioners researching how to get LETYBO®, a few things are worth confirming before you commit to a supplier:

• Verify the supplier’s authorization and distributor credentials
• Confirm cold-chain compliance and temperature-controlled shipping, which is mandatory for lyophilized BTX-A products like this one
• Request LOT number documentation and certificates of authenticity for the specific batch
• Check licensing and import requirements for your specific jurisdiction

Practitioners who want to buy LETYBO® wholesale for multi-practitioner clinics should pay particular attention to shipping conditions, since temperature excursions during transit can compromise product stability.

If you want to buy LETYBO® online or need further guidance, Medical Spa Rx support staff can help. Get in touch for information on product documentation, sourcing from verified suppliers, cold-chain shipping requirements, and other clinically relevant considerations before you purchase LETYBO® online for the first time.

Frequently Asked Questions

What is LETYBO®?

LETYBO® is a letibotulinumtoxinA injectable manufactured by Hugel Inc. in South Korea. It received FDA approval in 2024 for the temporary improvement of moderate to severe glabellar lines in adults, establishing it as the first FDA-approved letibotulinumtoxinA product for this indication. LETYBO® and BOTULAX® are both manufactured by Hugel and share the same INN (letibotulinumtoxinA), but BOTULAX® is the international trade name and has not received FDA approval.

Is LETYBO® FDA approved?

Yes. LETYBO® received FDA approval in 2024 for the temporary improvement of moderate to severe glabellar lines in adults and is also CE-marked for use in the European Union and the United Kingdom. This FDA approval represents LETYBO®’s primary clinical and commercial differentiator within Hugel’s botulinum toxin portfolio, as BOTULAX® has not received FDA approval despite sharing the same manufacturer.

How is LETYBO® different from BOTOX®?

They are manufactured by different companies and contain different active ingredients: letibotulinumtoxinA for LETYBO® (Hugel Inc.) and onabotulinumtoxinA for BOTOX® (AbbVie). Phase III clinical trials demonstrated that 20 units of LETYBO® achieved efficacy comparable to 20 units of BOTOX® for the treatment of moderate to severe glabellar lines [2]. However, botulinum toxin products are not unit-interchangeable, and practitioners should always follow the dosing recommendations specific to the product being administered.

How long does LETYBO® last?

Most patients start seeing effect somewhere between 3 and 7 days after injection, with the full LETYBO® results settling in by 10 to 14 days. For glabellar lines, that effect generally holds for 3 to 4 months. As for whether it outlasts BOTOX®, the trial data does not support that claim. No meaningfully longer duration has been demonstrated.

Does LETYBO® need to be refrigerated?

Yes. Unopened LETYBO® vials should be stored under refrigerated conditions at 2°C to 8°C and must not be frozen [4]. Maintaining the recommended cold chain is important for preserving product stability and potency before use. Once reconstituted with sterile saline, the product should be handled according to the manufacturer’s instructions and used within 24 hours.

What are the side effects of LETYBO®?

LETYBO® has a safety profile consistent with other botulinum toxin type A products, supported by clinical studies for FDA approval [1]. Common side effects include injection-site bruising, mild swelling, localized pain, and headache, which are usually mild, transient, and self-limiting. Eyelid ptosis may occur after upper-face treatment, typically related to technique, anatomy, or placement rather than the product itself.

Who makes LETYBO®?

LETYBO® is manufactured by Hugel Inc., a South Korean pharmaceutical company specializing in botulinum toxin products for aesthetic and therapeutic use. Hugel also manufactures BOTULAX®, which contains the same active substance (letibotulinumtoxinA) under a different trade name used in international markets. LETYBO® is FDA-approved for the temporary improvement of moderate to severe glabellar lines in adults, whereas BOTULAX® has not received FDA approval.

Where can practitioners find information on LETYBO®?

Healthcare professionals seeking additional information about LETYBO® can contact the Medical Spa Rx support team for guidance on product documentation, verified supplier information, cold-chain storage requirements, and clinically relevant sourcing considerations. The team can also assist with information on availability and ordering options for licensed practitioners.

The page and all of its displayed contents are for medical professionals, designed to inform only, and not as a replacement for medical advice.

References

[1] Mueller DS, Prinz V, Adelglass J, et al. Efficacy and Safety of Letibotulinumtoxin A in the Treatment of Glabellar Lines: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study. Aesthet Surg J. 2022;42(6):677-688. doi:10.1093/asj/sjac019 

[2] Kim BJ, Kwon HH, Park SY, et al. Double-blind, randomized non-inferiority trial of a novel botulinum toxin A processed from the strain CBFC26, compared with onabotulinumtoxin A in the treatment of glabellar lines. J Eur Acad Dermatol Venereol. 2014;28(12):1761-1767. doi:10.1111/jdv.12408 

[3] Center for Drug Evaluation and Research. Drug Trials Snapshots: LETYBO. US Food and Drug Administration; 2024. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-letybo

[4] Hugel Inc. LETYBO (letibotulinumtoxinA-wlbg) for injection: US Prescribing Information. US Food and Drug Administration; 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761225s000lbl.pdf

[5] Gold M, Taylor S, Mueller DS, et al. Efficacy and Safety of LetibotulinumtoxinA in the Treatment of Moderate and Severe Glabellar Lines in Females 35 to 50 Years of Age: Post Hoc Analyses of the Phase 3 Clinical Study Data. Aesthet Surg J Open Forum. 2024;6:ojae010. Published 2024 Feb 23. doi:10.1093/asjof/ojae010