Does Rejuran have FDA approval?

On 18 October 2026 we searched four FDA databases for “Rejuran”, “PharmaResearch” and “polynucleotide”: the premarket approval (PMA) database, the 510(k) database, the De Novo database and Drugs@FDA. The searches ran through the FDA’s openFDA data service (device data updated 5 October 2026, drug data 16 October 2026) and the De Novo search page. None returned a match.

A missing record does not mean the FDA rejected Rejuran or banned it. The FDA does not publish pending applications, so the public record only shows that no US authorisation has been issued. It also says nothing about how Rejuran was reviewed in other countries.

Compare SKINVIVE, a hyaluronic acid booster: its PMA record shows a decision on 11 May 2023 for cheek smoothness in adults over 21. That is what an FDA approval looks like in the database, and Rejuran has no equivalent entry.

Korea’s Ministry of Food and Drug Safety (MFDS) lists these Rejuran licences in its medical device database (checked 18 October 2026). All are Class 4, the highest of Korea’s four device risk classes, under the item “tissue-repair biomaterial”.

Sources: the Rejuran website’s Japanese disclosure, the Saudi Arabia press release and the European launch press release. The European release describes supply and launches; it does not name a certificate, so ask the clinic if you need the EU certification details.

FDA status answers one question: may this product be marketed in the United States for this use? For an American visitor it also affects aftercare at home, because a US doctor may not stock or know Rejuran. It does not answer whether the product was reviewed elsewhere. Rejuran’s Korean licence is a separate review by a different regulator, with its own licensed purpose.

The FDA authorises medical devices through three main routes. Premarket approval (PMA) is for the highest-risk devices and requires the maker to show safety and effectiveness, usually with clinical trials; devices that pass are “approved”. The 510(k) route is for devices shown to be substantially equivalent to one already on the market; those are “cleared”. De Novo is for new low- to moderate-risk devices with no equivalent; those are “granted”.

The dermal injectables with US records discussed on this site, SKINVIVE and Sculptra, both went through PMA. Medicines follow a separate route, the new drug application, which is the path Rejuran would face if the agency classed it as a drug rather than a device.

PharmaResearch has said it is preparing to seek US approval as a medical device and is targeting market entry around 2031–2032, according to a Korean business press report from August 2026. The same report notes that no polynucleotide skin booster has FDA approval to date, and that the agency could treat it as a drug instead, which would mean a longer and costlier route. Industry estimates quoted there put US approval six to ten years away.

The controlled trials are small. A randomised split-face trial of 27 adults found higher improvement rates for elasticity and hydration with polynucleotides than with non-cross-linked hyaluronic acid around the eyes ^[1], and a 30-person crow’s feet trial found no significant difference between Rejuran and a polycaprolactone filler at 12 weeks ^[2]. A 2026 expert review, co-written with PharmaResearch staff, reported no published granuloma or vascular occlusion cases and called for more randomised trials ^[3]. Polynucleotides should also not be confused with PDRN, which has different chain lengths and a different proposed mechanism ^[4].

Two Rejuran trials still quoted online were later retracted: a 2014 phase III crow’s feet trial (retraction notice, 2016) and a 2024 comparison with a polycaprolactone filler (retraction notice, 2026), withdrawn after the composition of the polycaprolactone product was misidentified.