Drugs / VX-880
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | type 1 diabetes mellitus | 2022-05-02 | “The company also announced the VX-880 Phase 1/2 study has been placed on clinical hold in the U.S. by the Food and Drug Administration (FDA)” vrtx.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT06832410 | Mar 2025 → Sep 2026 overdue | type 1 diabetes mellitus | Vertex Pharmaceuticals Incorporated | Recruiting | No outcome recorded |
| Phase 3 | NCT04786262 | Mar 2021 → Jun 2027 expected | type 1 diabetes mellitus | Vertex Pharmaceuticals Incorporated | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2025-06-30 | Hopstem Biotechnology Inc. | Results 2025【六月精选】领域最新进展 hopstem.com ↗
最新数据显示，12名接受全剂量治疗的伴有严重低血糖事件的1型糖尿病患者中， 10人（83%）在治疗后12个月内完全停用外源性胰岛素，且血糖控制达标率（HbA1c<7%、血糖目标范围内时间TIR>70%）达100%， 严重低血糖事件（SHE）完全消失。 |
| 2025-06-20 | Vertex Pharmaceuticals Incorporated | Results Vertex Presents Positive Data for Zimislecel in Type 1 Diabetes at the American Diabetes Association 85th Scientific Sessions vrtx.com ↗
All 12 patients with at least one year of follow-up who received a full dose of zimislecel as a single infusion achieved ADA-recommended target HbA1c levels <7% and >70% time-in-range (70-180 mg/dL), and 10/12 patients were insulin free |
| 2024-06-21 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Positive Results From Ongoing Phase 1/2 Study of VX-880 for the Treatment of Type 1 Diabetes Presented at the American Diabetes Association 84th Scientific Sessions vrtx.com ↗
Following a single infusion of VX-880 at the full dose, all 12 patients demonstrated islet cell engraftment and glucose-responsive insulin production by Day 90. |
| 2024-01-07 | Vertex Pharmaceuticals Incorporated | Results Vertex Provides Pipeline and Business Updates in Advance of Upcoming Investor Meetings vrtx.com ↗
Efficacy: As of the last data cut, all 14 patients dosed with VX-880 demonstrated islet cell engraftment and production of endogenous insulin. |
| 2023-10-03 | Vertex Pharmaceuticals Incorporated | Results Vertex Presents Positive, Updated VX-880 Results From Ongoing Phase 1/2 Study in Type 1 Diabetes at the European Association for the Study of Diabetes 59th Annual Meeting vrtx.com ↗
All patients in Part A and B now have more than 90 days of follow-up and have demonstrated islet cell engraftment and endogenous glucose-responsive insulin production on the Day 90 mixed-meal tolerance test (MMTT). |
| 2023-06-23 | Vertex Pharmaceuticals Incorporated | Results Vertex Presents Positive VX-880 Results From Ongoing Phase 1/2 Study in Type 1 Diabetes at the American Diabetes Association 83rd Scientific Sessions vrtx.com ↗
All six patients treated with VX-880 had undetectable fasting C-peptide (endogenous insulin secretion) at baseline, a history of recurrent SHEs in the year prior to treatment and required an average of 34.0 units of insulin per day. |
| 2022-07-05 | Vertex Pharmaceuticals Incorporated | Regulatory Vertex Announces FDA Has Lifted the Clinical Hold on VX-880 Phase 1/2 Clinical Trial for the Treatment of Type 1 Diabetes vrtx.com ↗ |
| 2022-06-06 | Vertex Pharmaceuticals Incorporated | Results Vertex Presents New Data from VX-880 Phase 1/2 Clinical Trial at the American Diabetes Association 82nd Scientific Sessions vrtx.com ↗
The data presented today show significant increases in the blood glucose time-in-range compared to baseline, following treatment with VX-880. |
| 2022-05-31 | Vertex Pharmaceuticals Incorporated | Results Vertex to Present New Data on VX-880 Clinical Trial at 82nd American Diabetes Association Annual Conference vrtx.com ↗
The abstract posted today details results from the Phase 1/2 clinical trial, demonstrating VX‑880 can restore insulin production and glucose control in T1D. |
| 2022-05-02 | Vertex Pharmaceuticals Incorporated | Results Vertex Provides Updates on Phase 1/2 Clinical Trial of VX-880 for the Treatment of Type 1 Diabetes vrtx.com ↗
The first patient dosed in Part A of the study achieved insulin independence at Day 270, with a HbA1c of 5.2%. |
| 2021-10-31 | Hopstem Biotechnology Inc. | Results 【十月精选】领域最新进展 hopstem.com ↗
2021年10月18日，Vertex Pharmaceuticals宣布，其同种异体干细胞的全分化胰岛细胞（VX-880）替代疗法，在1/2期临床试验的首例1型糖尿病患者（T1D）中获得积极数据。 |
| 2021-10-18 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Positive Day 90 Data for the First Patient in the Phase 1/2 Clinical Trial Dosed With VX-880, a Novel Investigational Stem Cell-Derived Therapy for the Treatment of Type 1 Diabetes vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive Day 90 data for the first patient from the Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for people with type 1 diabetes (T1D). |
| 2021-03-10 | Vertex Pharmaceuticals Incorporated | Regulatory Vertex Announces FDA Fast Track Designation and Initiation of a Phase 1/2 Clinical Trial for VX-880, a Novel Investigational Cell Therapy for the Treatment of Type 1 Diabetes vrtx.com ↗
We are very pleased to have received FDA’s Fast Track Designation, which facilitates the development and expedites the review of drugs that treat serious conditions and fill an unmet medical need. |
| 2021-01-28 | Vertex Pharmaceuticals Incorporated | Regulatory Vertex Announces FDA Clearance of Investigational New Drug (IND) Application for VX-880, a Novel Cell Therapy for the Treatment of Type 1 Diabetes (T1D) vrtx.com ↗
the U.S. Food and Drug Administration (FDA) has cleared the IND |
All press releases naming this drug 15 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VX-880 | “An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant” NCT06832410 ↗ |
| Action | Restore | “zimislecel can restore physiologic islet function” PMID 40544428 ↗ Jun 2025 |
| Modality | Cell therapy | “After zimislecel infusion, all the participants had engraftment and islet function” PMID 40544428 ↗ Jun 2025 |
| Route | Other | “Infused into the hepatic portal vein.” NCT04786262 ↗ |