What it is
PrabotulinumtoxinA is the generic name of a botulinum toxin type A manufactured by the South Korean company Daewoong Pharmaceutical. In the United States it is sold as Jeuveau by Evolus, and the FDA approved it in February 2019 for one cosmetic use: softening moderate to severe frown lines between the eyebrows in adults. The same toxin is sold in South Korea and other markets as Nabota, and in the European Union as Nuceiva.
Like other botulinum toxins, it is a bacterial protein that blocks the signal telling a muscle to contract. Injected into the frown muscles, it relaxes them for a few months before they recover. Its strength is measured in Units that the label says are specific to this product and cannot be converted into the Units of any other botulinum toxin.
The label describes prabotulinumtoxinA-xvfs as a 900 kDa botulinum toxin type A produced by fermentation of Clostridium botulinum, supplied as a sterile vacuum-dried powder containing the neurotoxin complex, human serum albumin and sodium chloride without preservative. The production strain is not named in the label. Potency is assigned by an animal-based assay against a product-specific reference standard, and one Unit corresponds to the calculated median intraperitoneal lethal dose in mice.
According to the label, the toxin binds acceptor sites on motor nerve terminals, enters the terminals and cleaves SNAP-25, a protein required for docking and release of acetylcholine from synaptic vesicles. At therapeutic intramuscular doses this produces partial chemical denervation and a localised reduction in muscle activity; the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop before reinnervation slowly reverses the effect. The label states that no formal pharmacodynamic or drug interaction studies were conducted and that the product cannot be detected in peripheral blood after intramuscular injection at recommended doses.
Who made it and when
Daewoong Pharmaceutical, based in Seoul, developed the toxin under the code name DWP-450 and first brought it to market in South Korea as Nabota. In September 2013 the California company Evolus took an exclusive licence to develop and sell it for aesthetic uses in the United States, Europe, Canada and several other markets, and ran the trials needed for approval.
The FDA approved Jeuveau on 1 February 2019, and the European Commission authorised it as Nuceiva in September 2019. Its early years in the US were shaped by a trade dispute: the rival Korean toxin maker Medytox and Allergan accused Daewoong of taking Medytox’s bacterial strain and manufacturing know-how. A 2021 settlement allowed Evolus to keep selling Jeuveau, and in October 2021 the trade commission vacated, meaning set aside, the ruling behind the dispute.
Evolus licensed DWP-450 from Daewoong in September 2013 for aesthetic indications in the US, EU, Canada and other territories. BLA 761085 received a complete response letter in May 2018 citing chemistry, manufacturing and controls issues, and was approved on 1 February 2019 with Evolus, Inc. as applicant and Daewoong as manufacturer, under the proper name prabotulinumtoxinA-xvfs. The EU marketing authorisation for Nuceiva (Evolus Pharma B.V.) followed on 27 September 2019, for glabellar lines in adults under 65 when the lines have an important psychological impact. The Korean approval date for Nabota is widely reported but was not confirmed here against a primary regulatory record.
In investigation 337-TA-1145, Medytox and Allergan alleged misappropriation of trade secrets relating to the bacterial strain and manufacturing process. The Commission’s December 2020 final determination found a violation and imposed a 21-month limited exclusion order. In February 2021 AbbVie, Medytox and Evolus settled; Evolus received a licence to continue selling Jeuveau in exchange for milestone and royalty payments. Daewoong was not a party. After the Federal Circuit dismissed the appeals as moot, the Commission vacated its final determination on remand on 28 October 2021.
What the data say
The US approval rests on two matched trials, EV-001 and EV-002, which together enrolled 654 adults with moderate to severe frown lines. Three in four received a single 20-Unit treatment given as five small injections, and one in four received saline. At day 30, the share of people improved by at least two grades on both the investigator’s and their own rating was 67% and 71% in the two trials, against 1% on placebo.
Headache was common in both groups, at 12% with the toxin and 13% with placebo. Drooping eyelid was reported in 2% of treated participants and none on placebo. Two open-label studies following more than 900 people through repeated treatments over a year reported a similar side-effect pattern.
EV-001 (NCT02334423) and EV-002 (NCT02334436) were randomised 3:1, double-blind, placebo-controlled, single-dose trials of identical design in 654 adults aged 18 to 81 (492 active, 162 placebo; mean age 51, 91% women, 84% white). Participants received 4 Units at each of five sites, 20 Units total. The primary endpoint was the proportion achieving at least a 2-grade improvement from baseline at maximum frown on both investigator and subject Glabellar Line Scale assessments at day 30: 67% versus 1% (EV-001, n=246 versus 84) and 71% versus 1% (EV-002, n=246 versus 78).
Adverse reactions more frequent than placebo by at least 1% were eyelid ptosis (2% versus 0%), upper respiratory tract infection (3% versus 1%) and white blood cell count increase (1% versus 0%); headache was similar between arms. The open-label repeat-treatment studies EV-004 (NCT02184988) and EV-006 (NCT02428608) enrolled 922 subjects with a median of three treatments and a maximum of 80 Units. Among 1,414 treated subjects, 2 had pre-existing antibodies and 2 developed treatment-emergent antibodies.
Regulatory picture
In the United States the only FDA-approved product containing prabotulinumtoxinA is Jeuveau, licensed to Evolus, and its only approved use is frown lines between the eyebrows in adults. The same toxin sold under the name Nabota, or under any other name, and brought in for import or online sale is not an FDA-approved product, even though it is licensed in South Korea and other countries.
The FDA has acted on this directly. In November 2025 it announced 18 warning letters to websites selling unapproved and misbranded botulinum toxin products, and at least one of those letters named products marketed under the Nabota name. The agency had already warned in April 2024 about counterfeit botulinum toxin reaching patients in several states. Pharmacy compounding does not apply to a licensed biologic like this one.
PrabotulinumtoxinA-xvfs is licensed under BLA 761085 under section 351 of the Public Health Service Act. As a biological product it falls outside the 503A bulk drug substances framework and no lawful route exists for a pharmacy to compound a copy, so the compounding field is recorded as not applicable. The label carries the class boxed warning for distant spread of toxin effect and states that Jeuveau Units are not interchangeable with those of other botulinum toxin products.
A US licence covers the approved product, its labelling and its controlled supply chain, not the molecule wherever it is sold. FDA’s 3 November 2025 warning letter to one website stated that, although FDA-approved botulinum toxin products are on the US market, no approved application was in effect for the Nabota-branded products offered; FDA treated them as unapproved new drugs and misbranded under the FD&C Act. That letter was part of the 18-letter action announced on 5 November 2025. The 2021 vacatur of the ITC determination did not alter Jeuveau’s licence or labelling.
