Drugs / Norditropin NordiFlex
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | NORDITROPIN FLEXPRO | — | 2004-11-01 – 2018-02-23 | fda.gov ↗ |
| Approved | US (FDA) | NORDITROPIN FLEXPRO | — | 2000-06-20 | fda.gov ↗ |
Trials 0
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT01706783 Comparator | Oct 2012 → Nov 2013 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2/3 | NCT07126288 Comparator | Aug 2025 → Sep 2028 expected | pituitary deficiency | Shenzhen Kexing Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Norditropin NordiFlex | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07126288 ↗ |
| Modality | Protein / enzyme biologic | “Once-daily injectable recombinant human growth hormone (GH) formulations” PMID 33864240 ↗ Apr 2021 |
| Route | Subcutaneous | “subcutaneous injection” NCT07126288 ↗ |