On September 9, 2026, Shionogi and StemRIM reported topline results for redasemtide (S-005151), an HMGB1-derived peptide, in two programs. The same-day PDF matches the HTML release.
The additional Phase 2 trial in dystrophic epidermolysis bullosa (DEB) met its primary endpoint of refractory ulcer closure in 3 of 4 patients. The global Phase 2b trial in acute ischemic stroke did not. In the cohort that did not undergo endovascular recanalization, modified Rankin Scale (mRS) at Day 90 showed no statistically significant difference versus placebo. The primary endpoint was not met.
A 3-of-4 primary in an open-label DEB study is a small-n signal. It is not marketing approval. A missed stroke primary is a miss. Redasemtide remains investigational. It is not FDA-approved for DEB or stroke.
This is the 10:07 Research Roundup for 12 September 2026. It is not an Industry News incretin story. Redasemtide is not a GLP-1, GIP, or amylin drug. It is not ARA-290. Yesterday's TT-P34 Phase I Parkinson note stays as written.
Pharmacally recapped the same sentences on 11 September 2026. That recap is secondary.
What happened on September 9
Shionogi, based in Osaka and led by Isao Teshirogi, Ph.D., announced results for a peptide in-licensed from StemRIM Inc., an Osaka University spin-out led by Masatsune Okajima. The companies call the candidate a regeneration-inducing medicine, a StemRIM trademark. That is branding. It is not a regulatory class.
DEB additional Phase 2. The primary endpoint was closure of refractory ulcers. The company says it was met in 3 of 4 patients. In certain cases, the release also reports favorable results for clinical symptoms, including total body ulcer area, and improvement in systemic symptoms. No ulcer-area percentages appear in the fetched topline. This article does not invent them. No new safety concerns were identified. Tolerability was described as favorable.
Stroke global Phase 2. Patients were treated within 25 hours of onset. In the cohort that did not undergo endovascular recanalization therapy (Shionogi's term for thrombolysis and mechanical thrombectomy), the primary endpoint was mRS at 90 days after the start of study drug. The redasemtide group did not show a statistically significant improvement compared with placebo. The trial did not achieve its primary endpoint.
Shionogi then describes a trend toward mRS improvement similar to a prior Japan Phase 2, and an exploratory subgroup trend in patients with higher severity at onset inside the non-endovascular cohort. Those sentences are company-described trends. They are not the primary result. Adverse-event incidence was comparable between redasemtide and placebo. No new safety concerns were identified there either.
For DEB, Shionogi says it will keep talking with StemRIM and will consider future development policy. For stroke, it will consider future policy after a detailed analysis. Those are next-step statements. They are not filings.
Why it matters
DEB is a serious rare skin disease. Shionogi estimates about 500 to 1,000 people with epidermolysis bullosa in Japan and says there is currently no fundamental treatment, citing the Japanese Dermatological Association and the Japan Intractable Diseases Information Center. That is disease background. It is not an efficacy result.
Acute ischemic stroke already has recanalization tools. Shionogi notes that eligible patients are limited and that applied therapy can still leave a gap. Revive was the late-stage test of whether a short intravenous peptide course could move 90-day disability in that gap. It did not meet the prespecified primary.
The split readout also lands against a May 12, 2026 StemRIM progress note. That PDF relayed Shionogi plans: a DEB preliminary by September 2026, a Japan filing in October 2026 to March 2027, and a fiscal 2027 launch window. Stroke had a September 2026 preliminary and an April 2028 to March 2031 launch window. Those dates were forward-looking. They were not a filed application. The September 9 release does not say a Japan NDA was filed.
DEB evidence
The company release cites jRCT2031220378 as Reference 1. The Japan Registry page, fetched 12 September 2026 from the Ministry of Health, Labour and Welfare host, titles the study as a Phase 2, multicenter, open-label, uncontrolled trial of S-005151 in DEB for intractable ulcers. Sponsor is Shionogi.
Design fields: single-arm, open (masking not used), uncontrolled, Japan only. Planned sample size is 3. First enrollment is 28 October 2022. The listed period runs to 30 September 2026. Recruitment status is not recruiting. Primary outcome is closure of intractable ulcer.
Inclusion requires DEB plus a refractory ulcer unclosed for 12 weeks or more, area of 4 cm2 or more, and no 50% or greater area reduction during pre-observation versus Visit 1. Named sites include Toho Omori, Ishikawa Prefectural Central, Osaka University, Fukuoka Children's, Kurume, and Hokkaido University Hospital.
The September 9 topline reports 4 patients and a 3-of-4 primary. The registry's planned N is 3. This article keeps both figures. It does not invent why they differ. Area and systemic-symptom notes are qualitative. No percentages appear. There is no fetched DEB adverse-event table.
n=4 is tiny. An open-label, uncontrolled design cannot separate drug effect from natural ulcer fluctuation or observer expectation. Meeting a primary in 3 of 4 patients is the claim Shionogi published. It is not a registration-quality treatment-effect estimate.
| Item | Published figure | Source |
|---|---|---|
| Design | Phase 2, open-label, uncontrolled, single arm | jRCT2031220378 |
| Planned N / company N | 3 / 4 | jRCT; Shionogi 9 Sept 2026 |
| Primary result | Refractory ulcer closure in 3 of 4 | Shionogi, 9 Sept 2026 |
| Other notes | Total body ulcer area and systemic symptoms improved in certain cases | Shionogi, 9 Sept 2026 |
| Ulcer-area percentages | Not disclosed in the Sept. 9 topline | Shionogi HTML and PDF |
| Safety | No new safety concerns; favorable tolerability | Shionogi, 9 Sept 2026 |
Stroke evidence
The company release cites jRCT2031230083 as Reference 2. That Japan record and ClinicalTrials.gov NCT05953480 describe the same Phase 2b program. The registry acronym is Revive on ClinicalTrials.gov and REvive on jRCT.
NCT05953480, queried 12 September 2026 via the ClinicalTrials.gov API, is COMPLETED. Lead sponsor is Shionogi. Official title: a Phase 2b, multinational, randomized, double-blind study of redasemtide versus placebo in adults with acute ischemic stroke. Actual start is 14 July 2023. Actual primary completion and completion are 15 June 2026. Last update posted is 30 July 2026. hasResults is false. The September 9 numbers are not on the registry.
Actual enrollment on ClinicalTrials.gov is 680. jRCT lists a planned sample size of 679. The September 9 topline does not publish an analyzed N, an mRS shift table, or a p-value. This article does not invent those figures. The 680 figure is a registry enrollment field. It is not a Shionogi-published primary-analysis N.
NCT splits the study into Cohort A (ineligible for systemic thrombolysis and/or mechanical recanalization) and Cohort B (eligible to receive, or already given, those therapies). Shionogi's published primary sits in the non-endovascular cohort. That maps to Cohort A. The release does not publish Cohort B results.
Design on NCT: randomized, parallel, double-blind. Window: within 25 hours. NIHSS 6 to 22. 150 locations across 17 countries. Primary: mRS at Day 90. Listed secondaries include mRS 0 to 2, Barthel Index, later mRS and NIHSS time points, and quality-of-life scales. None of those secondary numbers appear in the September 9 release.
Primary, as reported. No statistically significant improvement versus placebo on Day-90 mRS in the non-endovascular cohort. Primary not met.
Company-described trends. A trend toward mRS improvement, called similar to a prior Japan Phase 2. An exploratory subgroup analysis suggested a trend among patients with higher severity at onset in that same cohort. No cutoff, no delta, and no p-value are published for either trend. An exploratory subgroup is not primary success.
Safety, as reported. Adverse-event incidence comparable to placebo. No new safety concerns. Favorable tolerability. That is sponsor language. It is not a posted results module.
| Item | Published figure | Source |
|---|---|---|
| Design | Phase 2b, randomized, double-blind, placebo-controlled | NCT05953480; jRCT2031230083 |
| Registry status | COMPLETED; results not posted | NCT, 30 July 2026 |
| Actual / planned N | 680 / 679 | NCT; jRCT |
| Primary population | Non-endovascular-recanalization cohort | Shionogi, 9 Sept 2026 |
| Primary result | Day-90 mRS, no statistically significant difference vs placebo | Shionogi, 9 Sept 2026 |
| mRS deltas / p-values | Not disclosed in the Sept. 9 topline | Shionogi HTML and PDF |
| Exploratory note | Higher-severity subgroup trend | Shionogi, company-described |
| AE incidence | Comparable to placebo | Shionogi, 9 Sept 2026 |
What redasemtide is, and the registry doses
Shionogi describes redasemtide as a peptide created from HMGB1 (High Mobility Group Box 1), a nuclear protein that recruits mesenchymal stem cells to an affected area. The intended story is pharmacologic recruitment of the patient's own cells, without living-cell administration. The September 9 package does not publish a trafficking assay from either trial. The same About block lists chronic liver disease, osteoarthritis, and cardiomyopathy as other development areas. Those are pipeline claims, not efficacy results here.
A COA check can test whether a certificate names a real lab. It cannot turn a catalog vial into Shionogi's investigational peptide.
The September 9 topline does not publish milligram levels. Numeric doses below are registry protocol fields fetched 12 September 2026. They are trial assignments. Redasemtide is not approved for human use. That does not make a milligram-per-kilogram intravenous schedule an approved dose.
| Setting | Registry assignment | Source |
|---|---|---|
| DEB additional Phase 2 | 1.0 mg/kg intravenous; frequency not specified on the fetched line | jRCT2031220378 |
| Stroke Phase 2b route | Intravenous infusion once daily for 5 consecutive days | NCT05953480 |
| Stroke dose levels | 0.75 mg/kg and 1.5 mg/kg, or placebo (jRCT); NCT names Dose A / Dose B only | jRCT2031230083; NCT05953480 |
| Formulation on NCT | Lyophilized powder in 0.9% saline; redasemtide trifluoroacetate | NCT05953480 |
Do not treat 1.0 mg/kg, 0.75 mg/kg, or 1.5 mg/kg as a labeled or gray-market dose. Research-vendor vials, if they appear, are not the study drug. Use the vendor checklist and the COA verification guide before treating any certificate as proof.
Study design limits
The DEB study is open-label and uncontrolled. The planned registry N is 3. The company reports 4. Either way, the sample cannot support a precise effect size. There is no placebo ulcer-closure rate in this additional Phase 2. "Certain cases" for total body ulcer area is not a secondary endpoint table.
The stroke study is larger and blinded. The primary still missed. A company-noted similarity to a prior Japan Phase 2 does not rewrite the global primary. An exploratory higher-severity subgroup is a hypothesis generator.
Endovascular recanalization, in Shionogi's footnote, covers intravenous t-PA (selected within 4.5 hours) and mechanical thrombectomy (selected within 8 hours, or within 24 hours if conditions are met). The published primary population is the group that did not receive those therapies. Cohort B exists on the registry. Its results are unpublished in this topline.
NCT still has no posted results module. jRCT pages were fetched from jrct.mhlw.go.jp. The niph.go.jp English detail URLs failed TLS or returned HTTP 500 from this environment. IDs in the company release match the fetched MHLW records.
What did not change / what this does not mean
- 3 of 4 is not approval. The DEB primary was met in a tiny open-label study. The September 9 text does not announce a Japan filing.
- A missed stroke primary is not a soft win. No statistically significant Day-90 mRS difference versus placebo is the published result.
- An exploratory severity subgroup is not primary success. The company called it a suggested trend. No numbers were attached.
- May 12 filing and launch windows are not filings. They were StemRIM-relayed Shionogi plans.
- Pipeline mentions are not efficacy. Chronic liver disease, osteoarthritis, and cardiomyopathy remain development claims.
- Registry milligrams are not consumer doses. Redasemtide is not approved for DEB or stroke. That does not make 1.0 mg/kg or a 5-day IV course an approved dose.
- This is not medical advice, not a consumer protocol, and not a rewrite of rusfertide.
Redasemtide's unapproved status did not change on 12 September 2026. No PeptidePrices research page was created or updated. NCT05953480 did not gain a posted results module. SS-31 / elamipretide is a different peptide.
What to watch next
- A Japan DEB filing, if one is made. The May 12 window was a plan. The September 9 release says discussions continue.
- Posted Revive results. Look for analyzed N, the Day-90 mRS shift, Cohort A versus Cohort B, and the named severity subgroup. A press-release trend is not that table.
- A peer-reviewed DEB write-up. 3 of 4 needs methods, ulcer definitions, timing, and individual-patient detail.
- The stroke development decision. Shionogi said it will analyze first. A Phase 3 start, a pause, or a narrowed severity population would be a new fact.
- How later copy treats n=4. A rare-disease signal this small stays a signal until a larger, better-controlled package exists.
FAQs
Is redasemtide FDA-approved?
No. It is an investigational HMGB1-derived peptide. It is not approved for dystrophic epidermolysis bullosa, acute ischemic stroke, or any other use.
Did the DEB study prove redasemtide treats epidermolysis bullosa?
No. Shionogi reported refractory ulcer closure in 3 of 4 patients in an additional open-label Phase 2. That primary is not marketing approval and not a powered registration result.
Did the stroke trial succeed?
No. The global Phase 2b primary, Day-90 mRS in the non-endovascular-recanalization cohort, did not show a statistically significant difference versus placebo. Company-described trends are not that primary.
What dose was used?
The September 9 topline did not publish milligrams. jRCT lists 1.0 mg/kg IV for the DEB study and 0.75 or 1.5 mg/kg IV for stroke. NCT lists a once-daily IV infusion for 5 consecutive days. Redasemtide is not approved for human use. That does not make those assignments approved doses.
Is there a ClinicalTrials.gov record?
Yes. NCT05953480 is the completed global Phase 2b stroke study (Revive), actual enrollment 680, results not posted as of the 12 September 2026 query. The DEB additional Phase 2 is listed as jRCT2031220378.
This article is for general informational purposes only and is not medical advice. Talk to a licensed clinician about personal medical decisions. Redasemtide (S-005151) is an investigational peptide in company-reported Phase 2 programs. Nothing here is a dosing protocol, an availability claim, or a recommendation to obtain an unapproved product.
Continue your research
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