Drugs / mRNA-1403
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | norovirus infectious disease | 2025-02-14 | “The trial is currently on FDA clinical hold following a single adverse event report of a case of Guillain-Barré syndrome, which is currently under investigation.” q4web.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05992935 | Aug 2023 → Sep 2026 overdue | norovirus infectious disease | ModernaTX, Inc. | Active not recruiting | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT06592794 | Sep 2024 → Feb 2027 expected | gastroenteritis, norovirus infectious disease | ModernaTX, Inc. | Active not recruiting | Missed primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-07-31 | ModernaTX, Inc. | Results Moderna Reports Second Quarter 2026 Financial Results and Provides Business Updates q4web.com ↗
Moderna's Phase 3 safety and efficacy study of mRNA-1403 did not meet statistical criteria for early success at the Phase 3 interim analysis. |
| 2024-09-12 | ModernaTX, Inc. | Results Moderna R&D Day Highlights Progress and Strategic Priorities q4web.com ↗
An interim analysis showed that a single dose of mRNA-1403 elicited a robust immune response across all dose levels evaluated with a clinically acceptable reactogenicity and safety profile. |
| 2024-03-27 | ModernaTX, Inc. | Results Moderna Advances Multiple Vaccine Programs to Late-Stage Clinical Trials q4web.com ↗
An interim analysis showed that a single dose of mRNA-1403 elicited a robust immune response across all dose levels evaluated with a clinically acceptable reactogenicity and safety profile. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-31 | ModernaTX, Inc. | Moderna Reports Second Quarter 2026 Financial Results and Provides Business Updates q4web.com ↗ |
| 2024-09-30 | ModernaTX, Inc. | Moderna Announces First Participant Dosed in Pivotal Phase 3 Trial of Investigational mRNA Norovirus Vaccine, mRNA-1403 q4web.com ↗ |
| 2024-09-12 | ModernaTX, Inc. | Moderna R&D Day Highlights Progress and Strategic Priorities q4web.com ↗ |
| 2024-03-27 | ModernaTX, Inc. | Moderna Advances Multiple Vaccine Programs to Late-Stage Clinical Trials q4web.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mRNA-1403 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05992935 ↗ |
| Modality | Messenger RNA (mRNA) | “mRNA-1403 and mRNA-1405, Multivalent Candidate Vaccines” NCT05992935 ↗ |
| Route | Intramuscular | “2 intramuscular (IM) injections of mRNA-1403” NCT05992935 ↗ |