Redasemtide_Dosage, benefits & legal status
Also known as S-005151, KOI2, redasemtide trifluoroacetate
An experimental IV peptide meant to recruit your own stem cells, tested in skin disease, stroke and liver disease.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Redasemtide?
Plain language first. The technical label stays, but it never stands alone.Overview
The idea is that it draws mesenchymal stem cells out of the bone marrow and into the blood so they can home to injured tissue, with no cells given. It has orphan status in Japan for a genetic blistering disease, but its largest trial, a 680-person stroke study, missed its main goal in September 2026. It is not approved anywhere.
Redasemtide is the first 44 amino acids of HMGB1, a protein that damaged cells release, made synthetically and given into a vein. It was discovered at Osaka University and licensed to Shionogi in 2014.
What it's used for
An experimental IV peptide for tissue repair, tested in a blistering skin disease, stroke, liver fibrosis, knee cartilage and heart failure. The 680-person stroke trial missed its primary goal.
How does Redasemtide work?
What it does in the body, and where.Redasemtide copies the first 44 residues of HMGB1. It keeps the protein's box A region and omits box B, and its developers describe it as lacking the parts that switch on the inflammatory receptors TLR and RAGE.
- 01Stem cell mobilisationIn mice it raised the number of PDGFR-alpha and CD44 positive cells in the blood, a marker pair for bone marrow mesenchymal stem cells. A healthy-volunteer phase 1 also reported more of these cells than on placebo, without published numbers.
- 02Homing to damageThe proposed next step is that these cells travel to injured tissue and help repair it. The receptor the peptide acts on has not been identified.
- 03Open questionsIn a mouse liver study the authors could not confirm stem cell mobilisation in their own single-cell data and found no direct effect on macrophages, so how it works in the liver is unresolved.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Stroke
tested-and-failed- Human trialGlobal phase 2b REVIVE, 680 enrolled: in Cohort A (patients not eligible for clot removal) the day-90 disability score did not differ from placebo. Cohort B results were not disclosed.
- No dataAn earlier Japanese phase 2 in 150 patients was reported to meet its primary endpoint, with 34% against 18% reaching little or no disability at day 90. These figures come from Shionogi releases only, with no p-value or paper.
Epidermolysis bullosa
Investigational- Human trialInvestigator trial, 9 patients: blister and ulcer area fell significantly from baseline; 4 of 9 improved by half or more at 6 months.
- Human trialShionogi's follow-up trial in hard-to-heal ulcers: ulcers closed in 3 of 4 patients.
- No dataNeither trial had a control group.
Liver fibrosis
Investigational- Human trial10 people with chronic liver disease: fibrosis stage on biopsy improved in 4 of 10, and inflammation scores improved in 6 of 10 with none worse. Liver function did not improve significantly.
- No dataNo control group and no statistical hypothesis testing, so these are signals, not evidence of benefit.
It is not approved in Japan: it has orphan designation only, and a filing was planned for late 2026. 'The stroke trial was positive' refers to the 2021 Japanese phase 2, reported only in press releases without a p-value or paper; the 680-person global trial missed its primary endpoint in September 2026. The liver study did not show fibrosis reversal: 10 uncontrolled patients, no hypothesis testing, and only a trend in 5 of 10. It is not a stem cell therapy, because no cells are given. It is a 44-residue fragment, not the full HMGB1 protein.
The published record
Papers and trials about Redasemtide
1 papers tagged human · 0 not reviews or lab · 0 clinical trial publications
1 registered trials · none with posted results
Furthest stage reached: Phase 2, completed, no results posted
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Redasemtide
Evidence
Investigational
Category
Healing and recovery
Common vial
Varies
Half-life
Very short; no figure published
How much, and do you cycle it?
The range, and whether you take breaks.0.75 to 1.5 mg/kg daily for 5 days, or weekly (trial doses), daily for 5 days, or weekly for 4 weeks (trials). Short courses in the trials Trial dose
Given as a fixed course: five daily infusions after a stroke, four weekly infusions in liver disease, and five days of continuous infusion after heart bypass surgery. No trial has repeated a course.
Very short; no figure publishedTrial protocol
The liver paper says the peptide became undetectable in blood within a very short time and gives no figure or reference. The phase 1 report contains no pharmacokinetic data.
Source: Tsuchiya et al., Inflamm Regen 2026 (statement without data)
You can compare this against the whole library to see where it sits.
How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Stroke trials gave 0.75 or 1.5 mg/kg once daily for 5 days by IV infusion. The liver study gave 1.5 mg/kg over 90 minutes weekly for 4 weeks, or on days 1 to 4 and then weekly. The epidermolysis bullosa trial used 1.0 mg/kg. Healthy volunteers received single doses of 0.15 to 5.0 mg/kg, each in 100 mL of saline over 30 minutes. This is a hospital infusion, so no vial draw applies.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized Redasemtide keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 41% charged residues, 32% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Active cancer, or cancer within the last five years, excluded from most of its trials because it is designed to mobilise stem cells
- Current anticancer treatment, excluded from the global stroke trial
- Pregnancy or breastfeeding, excluded from every trial
- Blood thinners, excluded from the liver study
Stop and get help
- Chills, fever or a rash during or soon after an infusion
- Swelling of the face or throat, or trouble breathing
Common effects
- In the 10-person liver study, 6 people had a side effect (10 events in all); 2 were judged drug-related, both mild and brief: hoarseness and fever
- Chills, gum swelling, conjunctivitis and stomach pain also occurred in that study, not judged related
- Stroke trials reported side effects at rates similar to placebo, without numbers
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Redasemtide approved?
And where the numbers on this page come from.No. Redasemtide is not approved anywhere and is currently in company-run clinical trials. There is no legal route to obtain it outside a trial.
- Approval statusInvestigational
- RouteInto a vein (intravenous infusion)
- Checked11 October 2026
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesFDA GSRS substance record, redasemtide (UNII OVE619G496)Tsuchiya A et al., Inflammation and Regeneration 2026;46:23Shionogi, REVIVE and epidermolysis bullosa topline results (9 Sep 2026)ClinicalTrials.gov, REVIVE (NCT05953480)Shionogi, redasemtide stroke phase 2 summary (10 Apr 2023)Shionogi, orphan drug designation in Japan (24 May 2023)StemRIM, investigator phase 2 in epidermolysis bullosa (14 Jan 2020)US10550165B2 (Osaka University and StemRIM)
What has happened recently
Not approved anywhere. Japan's health ministry granted orphan designation for dystrophic epidermolysis bullosa in May 2023, and in May 2026 Shionogi planned a Japanese filing for that disease between October 2026 and March 2027. On 9 September 2026 it reported that the global stroke trial REVIVE (NCT05953480) missed its primary endpoint and said it would consider its future development policy. US or EU designations were not found.
You can compare this against the whole library, or read how to check a seller.
What else is like Redasemtide?
Others in Healing and recovery, side by side.If you're weighing Redasemtide, it's worth reading Retinalamin, Sigumir, and Thymosin Beta-15 in the same class.
An experimental IV peptide meant to recruit your own stem cells, tested in skin disease, stroke and liver disease.
- Dose
- 0.75 to 1.5 mg/kg daily for 5 days, or weekly (trial doses)
- How often
- Daily for 5 days, or weekly for 4 weeks (trials)
A Russian retina extract given by injection, from the same tradition as Cortexin.
- Dose
- 5 up to 10 mg per day
- How often
- Daily, in 10-day courses
A bioregulator for bone, joint, and cartilage health, with thin evidence.
- Dose
- Varies (course-based)
- How often
- Courses
A thymosin the research literature knows as a cancer marker, not a repair peptide.
- Dose
- Research only
- How often
- Not established
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- How to Read a Peptide COA
What the purity number does and does not tell you, and how to spot an edited report.
- How to Vet a Peptide Vendor
Independent COAs, HPLC purity, and the red flags that mean walk away.
Sources
- FDA GSRS substance record, redasemtide (UNII OVE619G496)(2026)Synthetic 44-residue peptide; INN redasemtide; code S-005151; CAS 1606186-88-2. Sequence identical to residues 1 to 44 of human HMGB1.
- Tsuchiya A et al., Inflammation and Regeneration 2026;46:23(2026)Open-label, uncontrolled phase 2 in 10 people with chronic liver disease, 1.5 mg/kg IV. Primary endpoint safety; no hypothesis testing. 5 of 10 showed a trend toward less fibrosis; no significant improvement in liver function. 2 drug-related adverse events, both grade 1.
- Shionogi, REVIVE and epidermolysis bullosa topline results (9 Sep 2026)(2026)Global stroke phase 2b, Cohort A: primary endpoint (modified Rankin Scale at day 90) not met. Epidermolysis bullosa phase 2: ulcer closure in 3 of 4 patients. No new safety concerns.
- ClinicalTrials.gov, REVIVE (NCT05953480)(2026)Randomised, double-blind, placebo-controlled, 680 enrolled at about 150 sites in 17 countries, within 25 hours of stroke onset. 0.75 or 1.5 mg/kg daily for 5 days. Completed; no results posted.
- Shionogi, redasemtide stroke phase 2 summary (10 Apr 2023)(2023)Japanese phase 2, 150 patients, 1.5 mg/kg for 5 days: modified Rankin Scale 0 to 2 at day 90 in 34% against 18% on placebo. No p-value or journal paper.
- Shionogi, orphan drug designation in Japan (24 May 2023)(2023)MHLW orphan designation for dystrophic epidermolysis bullosa.
- StemRIM, investigator phase 2 in epidermolysis bullosa (14 Jan 2020)(2020)9 patients: statistically significant reduction in blister and ulcer area. At 6 months after dosing, 7 of 9 were below baseline and 4 had improved by 50% or more.
- US10550165B2 (Osaka University and StemRIM)(2020)Describes the synthetic HMGB1 (1-44) peptide and its mobilisation of PDGFR-alpha and CD44 positive cells into the blood in mice.
Beyond these, 2 records are indexed. Browse the records