drugset
Drugs / insulin degludec/insulin aspart
last change Apr 2015 re-read 9 days ago

insulin degludec/insulin aspart

also known as IDegAsp · IDegAsp 50 · SIAM
Investigated by
Novo Nordisk A/S

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed US (FDA) Ryzodeg — 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 ↗

Trials 1

today NCT01865331 · Ph 1
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT01865331 Dec 2006 → Mar 2007 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded

Press releases naming this drug 16 releases

DateIssuerRelease
2013-01-21 Novo Nordisk A/S Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) får markedsføringstilladelse i Europa novonordisk.com ↗
2012-12-25 Novo Nordisk A/S Ryzodeg® (insulin degludec/insulin aspart) approved in Japan novonordisk.com ↗
2012-12-25 Novo Nordisk A/S Ryzodeg® (insulin degludec/insulin aspart) godkendt i Japan novonordisk.com ↗
2012-12-03 Novo Nordisk A/S Ryzodeg® (insulin degludec/insulin aspart) passed review by First Committee on Drugs of Pharmaceutical Affairs in Japan novonordisk.com ↗
2012-12-03 Novo Nordisk A/S Ryzodeg® (insulin degludec/insulin aspart) passerer evaluering i japansk medicinkomite novonordisk.com ↗
2012-11-08 Novo Nordisk A/S Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval from FDA Advisory Committee novonordisk.com ↗
2012-11-06 Novo Nordisk A/S FDA offentliggør briefingmateriale forud for mødet i den rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗
2012-11-06 Novo Nordisk A/S FDA posts briefing materials prior to Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
2012-10-25 Novo Nordisk A/S FDA offentliggør fokus for mødet i den rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗
2012-10-25 Novo Nordisk A/S FDA discloses focus of Advisory Committee meeting on insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
2012-10-19 Novo Nordisk A/S Novo Nordisk modtager positive udtalelser om Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) fra de europæiske registreringsmyndigheder novonordisk.com ↗
2012-10-19 Novo Nordisk A/S Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart) receive positive opinions from the European regulatory authorities novonordisk.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as insulin degludec/insulin aspart ClinicalTrials.gov intervention name — accepted as the source's own label NCT01865331 ↗
Known as IDegAsp “insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM)” NCT01865331 ↗
Known as IDegAsp 50 “insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM)” NCT01865331 ↗
Known as SIAM “insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM)” NCT01865331 ↗
Route Subcutaneous “Single dose of IDegAsp 50 administered subcutaneously (s.c., under the skin)” NCT01865331 ↗