Drugs / JPH034
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | multiple sclerosis | — | “Investigational New Drug (IND) application for JPH034 for the treatment of multiple sclerosis submitted to the U.S. Food and Drug Administration” j-pharma.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07534657 | Mar → Oct 2026 expected | — | J-Pharma Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-03-25 | J-Pharma Co., Ltd. | Regulatory Notice of Listing on the Tokyo Stock Exchange Growth Market j-pharma.com ↗
LAT1 inhibitor JPH034: The U.S. Food and Drug Administration (FDA) cleared its safety review of the Investigational New Drug (IND) application for multiple sclerosis on February 12, 2026 (U.S. time), and a Phase I clinical trial was initiated on March 22, 2026 in the United States. |
| 2026-02-19 | J-Pharma Co., Ltd. | Regulatory Notice of Approval for Listing on the Tokyo Stock Exchange Growth Market j-pharma.com ↗
LAT1 inhibitor JPH034: Received notification from the U.S. Food and Drug Administration (FDA), dated February 12, 2026 (U.S. time), that the safety review of the Investigational New Drug (IND) application submitted for the treatment of multiple sclerosis has been completed and that the Company may proceed with the initiation of the clinical trial. |
| 2026-02-16 | J-Pharma Co., Ltd. | Regulatory The IND Safety Review for JPH034 Has Been Completed, Advancing Toward Initiation of a Phase 1 Clinical Trial in the United States j-pharma.com ↗
The Company is now authorized to initiate clinical trials of JPH034 in the United States. |
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | JPH034 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07534657 ↗ |
| Route | Oral | “Oral JPH034” NCT07534657 ↗ |