Rituo and Rejuran — What Divided Them Was the Regulatory Pathway, Not the Material
“Which is better, Rituo or Rejuran?” Let us say it first: no study has compared the two directly in humans. And placed side by side, what separates them most is not the material but whether there was a legal duty to submit human clinical data before reaching the market. This does not mean one is of higher quality — it means that the same phrase “clinically verified” attached to both products stands on different procedures behind it.
The short answer
No study has compared Rituo (hADM, human acellular dermal matrix) and Rejuran (PN, polynucleotide) directly in humans. The biggest difference between the two products is not the material but the regulatory pathway. Rejuran is a medical device, so human clinical trial data was mandatory for its approval, and it passed a phase 3 trial with 72 enrolled and 70 analysed (J Korean Med Sci 2014;29(Suppl 3):S201–S209, Seoul National University Bundang Hospital). Rituo is human tissue under the Act on Safety and Management of Human Tissue, so it is distributed on a tissue bank licence alone and there was no legal duty to submit clinical trial data before marketing. An MFDS official also explained that “unlike a medical device, a separate clinical trial is not required.” A clinical paper on Rituo does exist — Int J Mol Sci 2026;27(5):2193 (Severance), 20 people · 20 weeks, registration number NCT07155278. But that study was carried out after launch (November 2024). That is, it is not “data submitted to obtain approval” but “data produced after going on sale.”
The comparison on one page
| Item | Rituo (hADM) | Rejuran (PN) |
|---|---|---|
| Material | Human acellular dermal matrix | Polynucleotide |
| Legal status | Human tissue under the Act on Safety and Management of Human Tissue | Medical device |
| Distribution requirement | Distributed on a tissue bank licence alone | Product approval — human clinical data mandatory |
| Duty to submit clinical data pre-market | There was none | There was |
| Human data | 20 people · 20 weeks (Int J Mol Sci 2026;27(5):2193, Severance, NCT07155278) | 70 analysed (J Korean Med Sci 2014;29(Suppl 3):S201–S209) |
| When that data was produced | After launch (November 2024) | Before approval |
| Trial design | Per the registration record, the treatment arm was hADM | Randomised, double-blinded, split-face, active-controlled |
| Result | 20-week follow-up | Improvement rate 95.7% (67/70) versus 94.3% (66/70), meeting a non-inferiority margin of −15% |
| What the trial demonstrated | At a scale of 20 people | As far as “not inferior to a hyaluronic acid product” |
| Adverse events | At 20 people, the denominator for an incidence is small | 31.9% versus 48.6% (p = 0.042) |
“We ran a clinical trial” points at different things
The same sentence — “we ran a clinical trial” — points at different things for the two products.
Rejuran’s phase 3 was a gate to obtaining approval. Without passing it the product could not have reached the market. That is why the design was randomised, double-blinded and active-controlled.
Rituo’s 20-person study is research carried out later on a product already on sale. This does not erase the value of the study — having one is better than not, and the presence of a registration number (NCT07155278) raises verifiability. But “data an approval demanded” and “data produced after launch” do not carry the same weight.
And the absence of a pre-market clinical duty is not a problem peculiar to Rituo but a condition of the whole hADM class. Celldem follows the same law. The class overall is set out in Celldem, Rituo and Rejuran — what differs.
What follows from being human tissue
That Rituo is human tissue changes more than the regulatory pathway.
- Because it is tissue derived from a donor, the tissue bank’s procurement, processing and record-keeping become the axis of safety. The items being managed are themselves different from those under a medical device approval.
- Lot-to-lot variation is different in character. A synthetic polymer is controlled to a compositional specification; for a human-derived material, the raw material is a person. We could not find data examining how that variation is reflected in clinical outcomes.
- A means of reversal does not apply to either product — neither is hyaluronic acid, so dissolving with hyaluronidase does not arise, and both are degradable materials.
So how do you choose
With no direct comparison, we frame it not as superiority but as what you are prioritising.
| What you prioritise | Which way it leans | Why |
|---|---|---|
| Clinical data that passed an approval review | Rejuran | Medical device phase 3, 70 analysed, active-controlled |
| Adverse-event data with a large denominator | Rejuran | 31.9% versus 48.6% (p = 0.042) — a figure with a control group |
| A preference for human-derived material | Rituo | But the basis of that preference is not outcome data |
| The existence of a recent paper | Rituo | Int J Mol Sci 2026;27(5):2193 — 20 people · 20 weeks, after launch |
Both products aim at the density and texture of the dermis. For change caused by lost volume, neither is the answer.
Frequently asked questions
Rituo is newer — doesn’t that make it better?
Launching later and having thicker data are different things. Rituo’s human data is 20 people over 20 weeks; Rejuran’s is a phase 3 with 70 analysed. But since no trial has compared the two directly, there is no data on either side with which to answer “better.”
Is human tissue safer, or less safe?
We could not find a trial comparing safety between the two classes. What is clear is that the management systems differ — a medical device is managed through product approval, human tissue through a tissue bank licence and record-keeping.
Why does it matter that Rituo has a trial registration number?
A registration number (NCT07155278) means the study was publicly registered at the point it began, which narrows the room to report only the favourable parts once results are in. That is why we treat verifiability as important.
Can I have both?
We could not find trial data on combining them. The order and interval have to be decided with your other treatment history on the table as well.
Are Celldem and Rituo the same thing?
Both are in the hADM class and follow the same law (the Act on Safety and Management of Human Tissue). The products differ, but the condition of having had no pre-market clinical submission duty is the same. The class overall is in Celldem, Rituo and Rejuran.
How do the session counts differ?
Rejuran’s phase 3 protocol was three sessions at 2-week intervals with 12-week follow-up — that number came out of the trial. Rituo’s session plan follows the product guidance, and we could not find a trial comparing outcomes by session count. Sessions by class are in how many sessions and how long does it last.
Who wrote this
Written and reviewed by Lee Chi-Hak, MD, medical director of Miso Clinic in Daegu, South Korea. Every study cited above is given together with its design, its size and the limitations the authors themselves recorded, and where we could not find data, we have said that we could not find any.
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|---|---|
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References
- J Korean Med Sci 2014;29(Suppl 3):S201–S209 — Rejuran (PN) phase 3, Seoul National University Bundang Hospital, 72 enrolled · 70 analysed, randomised, double-blinded, split-face, active-controlled, improvement 95.7% versus 94.3%, adverse events 31.9% versus 48.6% (p = 0.042).
- Int J Mol Sci 2026;27(5):2193, NCT07155278 — Rituo (hADM), Severance, 20 people · 20 weeks. Carried out after launch (November 2024).
- Act on Safety and Management of Human Tissue (Korea) — the legal status and distribution requirements of hADM. Distributed on a tissue bank licence alone, with no duty to submit clinical trial data before marketing.
- MFDS official’s explanation — “unlike a medical device, a separate clinical trial is not required.”
Everything in this column is general information and does not replace medical diagnosis or treatment. Effects and side effects vary with individual skin condition, age and underlying illness, and the same result is not guaranteed for everyone. Any decision to proceed should be made in an in-person consultation with a physician.
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