Drugs / Ersodetug
Ersodetug
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | congenital isolated hyperinsulinism | — | “interactions with FDA towards resolution of partial clinical holds” rezolutebio.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT04538989 | Feb 2020 → Apr 2022 | congenital isolated hyperinsulinism | Rezolute | Completed | No outcome recorded |
| Phase 2 | NCT02772718 | Apr 2016 → May 2021 | hypoglycemia | XOMA (US) LLC | Completed | Met primary |
| Phase 2 | NCT02604485 | Oct 2015 → Jan 2017 | congenital isolated hyperinsulinism | XOMA (US) LLC | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06881992 | Apr 2025 → Sep 2027 expected | hyperinsulinism | Rezolute | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT07262970 | — | hyperinsulinemic hypoglycemia | Rezolute | Available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT06208215 Comparator | Jan 2024 → Nov 2025 overdue | congenital isolated hyperinsulinism | Rezolute | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 27
| Date | Issuer | Release |
|---|---|---|
| 2026-06-17 | Rezolute | Results Rezolute Highlights Results Presented from Natural History Outcomes Studies and its Ersodetug Clinical Program in Hyperinsulinism at Annual Meeting of the Endocrine Society rezolutebio.com ↗ |
| 2026-06-02 | Rezolute | Results Rezolute Announces Positive Interim Data for its Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism rezolutebio.com ↗
Each of these 6 participants also achieved a complete discontinuation of intravenous glucose requirements with the administration of ersodetug. |
| 2026-05-12 | Rezolute | Results Rezolute Reports Third Quarter Fiscal 2026 Financial Results and Provides Business Update rezolutebio.com ↗
In addition to the previously reported topline results, the presentation included results from additional continuous glucose monitoring (CGM)-based outcomes, which demonstrated significant and consistent improvements in glycemic control in ersodetug treatment arms compared to placebo, across multiple pre-specified and post-hoc endpoints. |
| 2026-05-01 | Rezolute | Results Rezolute Announces Oral Presentation of Results From its Phase 3 sunRIZE Study of Ersodetug in Patients with Congenital Hyperinsulinism at the Pediatric Endocrine Society Annual Meeting rezolutebio.com ↗
In addition to the previously reported topline results, the presentation included additional results from pre-specified and post-hoc sunRIZE analyses, which the Company believes reiterates evidence of target engagement and highlights the potential therapeutic benefit of ersodetug. |
| 2026-01-07 | Rezolute | Results Rezolute Provides Insights from its Phase 3 sunRIZE Study in Congenital Hyperinsulinism and Shares Findings from its Expanded Access Program in Tumor Hyperinsulinism rezolutebio.com ↗
While sunRIZE did not meet its primary (hypoglycemia events) or key secondary (time in hypoglycemia) endpoints, the Company believes that the totality of the data further supports previous clinical evidence that ersodetug is active against hypoglycemia in patients. |
| 2025-12-11 | Rezolute | Results Rezolute Announces Phase 3 sunRIZE Study Results in Congenital Hyperinsulinism rezolutebio.com ↗
Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today announced topline results from its Phase 3 sunRIZE study evaluating ersodetug in patients with congenital hyperinsulinism (HI). |
| 2025-05-05 | Rezolute | Regulatory Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Tumor Hyperinsulinism rezolutebio.com ↗
Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by HI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its investigational therapy, ersodetug, for the treatment of hypoglycemia caused by tumor HI. |
| 2025-02-04 | Rezolute | Results Rezolute Provides Update on its Phase 3 sunRIZE Study of Ersodetug for the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism rezolutebio.com ↗
Open-label arm (infant participants < 1 year old) has been recently reviewed by a Data Monitoring Committee (DMC) and target drug concentrations were safely reached at tested doses |
| 2025-01-07 | Rezolute | Regulatory Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism rezolutebio.com ↗
Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ersodetug (RZ358) for the treatment of hypoglycemia due to congenital HI. |
| 2024-12-03 | Rezolute | Regulatory FDA Grants Orphan Drug Designation to Rezolute’s Ersodetug (RZ358) for the Treatment of Hypoglycemia Due to Tumor Hyperinsulinism rezolutebio.com ↗
Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ersodetug for the treatment of hypoglycemia due to tumor HI. |
| 2024-09-09 | Rezolute | Regulatory FDA Lifts Partial Clinical Holds on RZ358 for the Treatment of Congenital Hyperinsulinism and Authorizes U.S. Inclusion in Ongoing Phase 3 Study rezolutebio.com ↗ |
| 2024-08-05 | Rezolute | Regulatory Rezolute Announces FDA Clearance of IND Application for Phase 3 Registrational Study of RZ358 for Treatment of Hypoglycemia Due to Tumor Hyperinsulinism rezolutebio.com ↗ |
| 2024-03-06 | Rezolute | Results Rezolute Reports Validation of the Potential Use of RZ358 for Treatment of Non-Islet Cell Tumor Hypoglycemia (NICTH) rezolutebio.com ↗ |
| 2024-01-23 | Rezolute | Regulatory Rezolute Receives Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group for RZ358 in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism rezolutebio.com ↗
Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the innovative medicine designation, the Innovation Passport, to RZ358 for the treatment of hypoglycemia due to congenital hyperinsulinism (HI). |
| 2023-10-17 | Rezolute | Regulatory Rezolute Receives Priority Medicines (PRIME) Eligibility from European Medicines Agency for Enhanced Regulatory Support of RZ358 in Congenital Hyperinsulinism rezolutebio.com ↗
Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) eligibility to RZ358 for the treatment of congenital hyperinsulinism (HI). |
| 2023-10-11 | Rezolute | Results Rezolute Announces Further Evidence of RZ358’s Efficacy in Tumor-Mediated Hyperinsulinism rezolutebio.com ↗
Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced results following administration of RZ358 to a patient with refractory hypoglycemia due to tumor-mediated hyperinsulinism (tmHI) on a compassionate-use basis, under its expanded access program (EAP). |
| 2022-05-01 | Rezolute | Results Rezolute Announces Positive Data from its Phase 2b (RIZE) Study of RZ358 in Patients with Congenital Hyperinsulinism rezolutebio.com ↗ |
| 2022-03-23 | Rezolute | Results Rezolute Announces Positive Results from the Phase 2b RIZE Study of RZ358 in Congenital Hyperinsulinism rezolutebio.com ↗
Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today announced positive data from its Phase 2b RIZE study of RZ358. |
| 2021-09-22 | Rezolute | Results Rezolute Presents Results from Two-Week Natural History Study in Congenital Hyperinsulinism Patients on Standard of Care Therapies at ESPE 2021 rezolutebio.com ↗ |
| 2021-03-22 | Rezolute | Results Rezolute Presents Data on RZ358 in Post-Gastric Bypass Hypoglycemia at ENDO 2021 rezolutebio.com ↗
Rezolute, Inc. (“Rezolute” or “the Company”) (Nasdaq: RZLT) today presented positive results of a Phase 2a study of RZ358 in patients with post-gastric bypass hypoglycemia (PGBH), as well as results of a pharmacologic model of the drug candidate, at the Endocrine Society’s Annual Meeting, ENDO 2021, held virtually from March 20 through March 23. |
| 2020-06-10 | Rezolute | Regulatory Rezolute Receives Rare Pediatric Disease Designation for RZ358, Phase 2b Candidate for the Treatment of Congenital Hyperinsulinism, Enabling Eligibility for Priority Review Voucher rezolutebio.com ↗ |
| 2020-06-01 | Rezolute | Results Rezolute Presents RZ358 Clinical Data-Validated Model of the Pharmacokinetics and Glycemic Response in Congenital Hyperinsulinism at Pediatric Endocrine Society 2020 Annual Meeting rezolutebio.com ↗
Rezolute, Inc. (“Rezolute” or “the Company”) (OCTQB:RZLT) recently announced that it has validated pharmacokinetic (PK) and pharmacodynamic (PD) models of its lead clinical asset, RZ358. |
| 2016-10-19 | XOMA (US) LLC | Regulatory XOMA Announces Significant Step Toward Initiating Pediatric Phase 2 Clinical Study for XOMA 358 in Children with Congenital Hyperinsulinism xoma.com ↗
Additionally, the regulatory body in Germany recently approved our plan to conduct a repeat-dose clinical study in CHI patients over the age of 12. |
| 2016-09-15 | XOMA (US) LLC | Results XOMA Provides Update from Ongoing Phase 2 XOMA 358 Clinical Studies xoma.com ↗
The initial data from the XOMA 358 Phase 2 clinical studies confirms that our first-in-class allosteric antibody is exhibiting an inhibition on insulin signaling, the desired mechanism-of-action. |
| 2016-07-20 | XOMA (US) LLC | Regulatory XOMA Receives Orphan Drug Designation in the European Union for XOMA 358 for Treatment of Congenital Hyperinsulinism xoma.com ↗
today announced the European Medicines Agency (EMA) has granted Orphan Drug Designation to XOMA 358 for the treatment of congenital hyperinsulinism (CHI) |
| 2015-06-16 | XOMA (US) LLC | Regulatory XOMA Receives Orphan Drug Designation for XOMA 358 From U.S. FDA for Treatment of Congenital Hyperinsulinism (HI) xoma.com ↗
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today XOMA 358, a fully human allosteric monoclonal antibody that reduces both the binding of insulin to its receptor and downstream insulin signaling, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of congenital hyperinsulinism (HI). |
| 2015-03-07 | XOMA (US) LLC | Results XOMA Presents Positive Phase 1 XOMA 358 Data at the ENDO Meeting xoma.com ↗
The XOMA 358 Phase 1 data is the first to show that a monoclonal antibody can down-regulate the insulin receptor and its downstream signaling. |
All press releases naming this drug 44 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ersodetug | “Global, multi-center, repeat-dose, phase 2 study of RZ358 (ersodetug), an insulin receptor antibody, for congenital hyperinsulinism.” PMID 40107271 ↗ Mar 2025 |
| Known as | RZ358 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06208215 ↗ |
| Known as | XMetD | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314739 ↗ |
| Known as | XOMA 247 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314739 ↗ |
| Known as | XOMA 358 | “XOMA 358 single dose level A administered by an intravenous infusion” NCT02604485 ↗ |
| Modality | Monoclonal antibody | — CHEMBL5314739 ↗ |
| Route | Intravenous | “administered by an intravenous infusion” NCT02604485 ↗ |