insulin degludec/insulin aspart
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Ryzodeg | diabetes mellitus, congenital autoimmune | 2015-04-07 | “de amerikanske sundhedsmyndigheder (FDA) har accepteret de genindsendte registreringsansøgninger for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart)” novonordisk.com ↗ “the US Food and Drug Administration (FDA) has accepted for review the Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart).” novonordisk.com ↗ “FDA) has accepted for review the Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart).” novonordisk.com ↗ |
| Rejected (CRL) | US (FDA) | Ryzodeg | diabetes mellitus, congenital autoimmune | 2013-02-08 | “Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg®” novonordisk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01134224 | May → Nov 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
Press releases naming this drug 16 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | insulin degludec/insulin aspart | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01134224 ↗ |
| Known as | IDegAsp | “The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.” NCT01134224 ↗ |
| Known as | NN5401 | “The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.” NCT01134224 ↗ |