Drugs / copper histidinate
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Menkes disease 2 milestones | |||||
| Rejected (CRL) | US (FDA) | — | Menkes disease | 2025-10-01 | “the U.S. Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) relating to its New Drug Application (NDA) for copper histidinate (CUTX-101)” sentynl.com ↗ |
| Filed | US (FDA) | — | Menkes disease | 2021-12-15 | “today announced the initiation of a rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for CUTX-101” sentynl.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | ZYCUBO | — | 2026-01-12 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT04074512 | — | Menkes disease | Sentynl Therapeutics, Inc. | Approved for marketing | Met primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-01-13 | Sentynl Therapeutics, Inc. | Regulatory Sentynl Therapeutics Inc. Announces FDA Approval of ZYCUBO® (copper histidinate) sentynl.com ↗
Sentynl Therapeutics Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences Limited (“Zydus Group”), announced that the U.S. Food and Drug Administration (“FDA”) has approved ZYCUBO® (copper histidinate) for the treatment of Menkes disease in pediatric patients. |
| 2025-12-15 | Sentynl Therapeutics, Inc. | Regulatory Sentynl Therapeutics Announces FDA Acceptance of CUTX-101 NDA Resubmission sentynl.com ↗
Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (“Zydus Group”), today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (“NDA”) for copper histidinate (CUTX-101), intended to treat Menkes disease in pediatric patients. |
| 2025-10-01 | Sentynl Therapeutics, Inc. | Regulatory Sentynl Therapeutics updates on its NDA for CUTX-101 sentynl.com ↗
Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (“Zydus”), announced today that the U.S. Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) relating to its New Drug Application (NDA) for copper histidinate (CUTX-101), intended to treat Menkes disease in pediatric patients. |
| 2025-01-06 | Sentynl Therapeutics, Inc. | Regulatory Sentynl Therapeutics Announces U.S. FDA Acceptance and Priority Review of New Drug Application for CUTX-101 (Copper Histidinate) Product Candidate for Treatment of Menkes Disease sentynl.com ↗
Six-month priority review granted for CUTX-101 copper histidinate with PDUFA target action date set for June 30, 2025 |
| 2022-03-21 | Sentynl Therapeutics, Inc. | Results Fortress Biotech, Cyprium Therapeutics and Sentynl Therapeutics Announce CUTX-101, Copper Histidinate, Data to be Presented at 2022 American College of Medical Genetics Annual Clinical Genetics Meeting sentynl.com ↗
The previously reported results are from an efficacy and safety analysis of data integrated from two completed pivotal studies in patients with Menkes disease treated with CUTX-101. |
| 2021-12-15 | Sentynl Therapeutics, Inc. | Regulatory Fortress Biotech, Cyprium Therapeutics and Sentynl Therapeutics Announce the Initiation of Rolling Submission of a New Drug Application for CUTX-101, Copper Histidinate, for Treatment of Menkes Disease sentynl.com ↗
We are very pleased to have initiated the rolling submission of our NDA to the FDA for CUTX-101, an important milestone for Cyprium. |
| 2021-10-08 | Sentynl Therapeutics, Inc. | Results Fortress Biotech and Cyprium Therapeutics Announce Positive Clinical Data for CUTX-101, Copper Histidinate, Presented at 2021 American Academy of Pediatrics National Conference & Exhibition sentynl.com ↗
In both pre-specified primary and secondary efficacy analyses, treatment with CUTX-101 demonstrated a significantly greater median overall survival (OS) compared to untreated historical control patients. |
All press releases naming this drug 9 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 | copper histidinate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04074512 ↗ |
| Route | Subcutaneous | “copper histidinate for subcutaneous injection” NCT04074512 ↗ |