Drugs / SR-02
last change Apr 2025 re-read 3 minutes ago

SR-02

Cell therapy

Developed for
type 1 diabetes mellitus
Investigated by
Seraxis

Trials 2

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT07581197 Nov 2026 → Nov 2028 expected type 1 diabetes mellitus Seraxis Not yet recruiting No outcome recorded
Phase 1/2 NCT06651515 Apr 2025 → Mar 2027 type 1 diabetes mellitus Seraxis Withdrawn No outcome recorded Stop: Business

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2024-10-15 Seraxis Regulatory Seraxis Announces FDA IND Allowance for Clinical Study of SR-02 Replacement Islets for Type 1 Diabetes seraxis.com ↗
Seraxis Inc., a clinical stage regenerative medicine company, has received FDA’s allowance of an Investigational New Drug (IND) application for a Phase I/II clinical study of its novel islet replacement therapy SR-02.
2023-10-26 Seraxis Results Seraxis Announces Publication of Preclinical Data for a Novel Islet Replacement Therapy and Clinical Candidate SR-02 for Insulin-Requiring Diabetes; Oral Presentation at IPITA. seraxis.com ↗
Seraxis Announces Publication of Preclinical Data for a Novel Islet Replacement Therapy and Clinical Candidate SR-02 for Insulin-Requiring Diabetes; Oral Presentation at IPITA.
2023-09-28 Seraxis Results Seraxis to provide oral update on its pancreatic organoid candidate for functional cure of T1D at the 59th Annual Meeting of the EASD. seraxis.com ↗
In themouse model of STZ induced Type 1 Diabetes, organoid implantation resulted in glycemiccontrol 3-4 weeks post-implant.

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as SR-02 “SR-02 allogeneic pancreatic endocrine cell clusters” NCT07581197 ↗
1

“SR-02 Allogeneic pancreatic endocrine cell clusters” NCT06651515 ↗

Modality Cell therapy “Allogeneic Pancreatic Endocrine Cell Clusters” NCT06651515 ↗
Route Other “SR-02 administered to the omentum” NCT06651515 ↗