What it is
PrabotulinumtoxinA is a type of botulinum toxin (type A). It is made by Daewoong Pharmaceutical, a company in South Korea. In the United States, a company called Evolus sells it as Jeuveau. The FDA approved it in February 2019 for one beauty use. That use is softening moderate to severe frown lines between the eyebrows in adults. The same toxin is sold as Nabota in South Korea and some other countries. In the European Union it is sold as Nuceiva.
Like other botulinum toxins, it is a protein made by bacteria. It blocks the signal that tells a muscle to tighten. When it is injected into the frown muscles, they relax for a few months. Then the muscles slowly start working again. Its strength is measured in Units. The label says these Units belong to this product only. They cannot be changed 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 is based in Seoul. It developed the toxin under the code name DWP-450. It first sold it in South Korea as Nabota. In September 2013, Evolus, a company in California, got the sole rights to develop and sell it for beauty uses. This covered the United States, Europe, Canada and several other places. Evolus ran the trials needed for approval.
The FDA approved Jeuveau on 1 February 2019. Europe approved it as Nuceiva in September 2019. Its early years in the US included a trade fight. A rival Korean toxin maker, Medytox, and the company Allergan made a claim against Daewoong. They said Daewoong took Medytox’s bacteria and its know-how for making the toxin. A settlement in 2021 let Evolus keep selling Jeuveau. In October 2021, the US trade commission set aside the ruling at the center of the fight.
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 is based on two matching trials, called EV-001 and EV-002. Together they included 654 adults with moderate to severe frown lines. Three in four got one 20-Unit treatment, given as five small shots. One in four got salt water as a dummy treatment (placebo). The trials checked people at day 30. Success meant the lines improved by at least two grades. Both the doctor and the person had to see this. It happened in 67% and 71% of people in the two trials. On placebo, it happened in 1%.
Headache was common in both groups. It happened in 12% of people on the toxin and 13% on placebo. A drooping eyelid happened in 2% of treated people and in no one on placebo. Two more studies followed more than 900 people who got repeat treatments over a year. In those studies, everyone knew they were getting the toxin. The side effects were similar to the first trials.
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, Jeuveau is the only FDA-approved product with prabotulinumtoxinA. Evolus holds the US rights to it. Its only approved use is frown lines between the eyebrows in adults. The same toxin may be sold as Nabota or under another name. If it is brought into the US or sold online, it is not an FDA-approved product. This is true even though it is approved in South Korea and other countries.
The FDA has taken action on this. In November 2025, it announced 18 warning letters to websites. These sites sold botulinum toxin products that were not approved and were illegally labelled (misbranded). At least one letter named products sold as Nabota. In April 2024, the FDA had already warned about fake botulinum toxin. Those fakes had been given to people in several states. Pharmacies cannot legally make their own copies of a licensed product 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.
