insulin degludec/insulin aspart

also known as IDegAsp · NN5401

Developed for: type 1 diabetes mellitus
Investigated by: HNEC TEST · Novo Nordisk A/S

Trials 1

today NCT01138488 · Ph 1

201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 1	NCT01138488	Jun → Nov 2010	type 1 diabetes mellitus	Novo Nordisk A/S	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 15

Date	Issuer	Release
2025-08-28	Gan and Lee Pharmaceuticals, USA	Results Gan & Lee Pharmaceuticals' Preclinical Results of Novel Premixed Insulin GZR101 Published in Naunyn-Schmiedeberg's Archives of Pharmacology ganlee.com ↗ The results demonstrate that GZR101 exhibits favorable pharmacokinetic (PK) and pharmacodynamic (PD) characteristics.
2015-09-25	Novo Nordisk A/S	Regulatory Novo Nordisk får FDA-godkendelse for Tresiba® og Ryzodeg® 70/30 i USA novonordisk.com ↗ Bagsværd, den 25. september 2015 - Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder (FDA) efter at have afsluttet behandlingen af de genindsendte registreringsansøgninger har godkendt Tresiba® og Ryzodeg® 70/30 til behandling af diabetes hos voksne.
2015-04-07	Novo Nordisk A/S	Regulatory Novo Nordisk A/S: Amerikanske FDA accepterer at behandle genindsendelserne af Tresiba® og Ryzodeg® novonordisk.com ↗ Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder (FDA) har accepteret de genindsendte registreringsansøgninger for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) til behandling som en 'Class II Resubmission'.
2015-04-07	Novo Nordisk A/S	Regulatory US FDA accepts Tresiba® and Ryzodeg® resubmissions for review novonordisk.com ↗ Novo Nordisk today announced that 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).
2013-02-10	Novo Nordisk A/S	Regulatory Novo Nordisk receives Complete Response Letter in the US for Tresiba® and Ryzodeg® novonordisk.com ↗ Novo Nordisk today announced that on 8 February 2013 it received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart).
2013-02-10	Novo Nordisk A/S	Regulatory Novo Nordisk modtager Complete Response Letter i USA vedrørende Tresiba® og Ryzodeg® novonordisk.com ↗ Bagsværd, den 10. februar 2013 - Novo Nordisk meddeler i dag, at virksomheden den 8. februar 2013 har modtaget et såkaldt Complete Response Letter fra de amerikanske sundhedsmyndigheder, FDA, vedrørende registreringsansøgningerne for Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart).
2013-01-21	Novo Nordisk A/S	Regulatory Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) får markedsføringstilladelse i Europa novonordisk.com ↗ Bagsværd, den 21. januar 2013 - Novo Nordisk meddelte i dag, at Europa-Kommissionen har givet markedsføringstilladelse til Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) til behandling af diabetes hos voksne.
2013-01-21	Novo Nordisk A/S	Regulatory Tresiba® and Ryzodeg® receive marketing authorisations in Europe novonordisk.com ↗ Novo Nordisk today announced that the European Commission has granted marketing authorisations for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart) for the treatment of diabetes in adults.
2012-12-25	Novo Nordisk A/S	Regulatory Ryzodeg® (insulin degludec/insulin aspart) godkendt i Japan novonordisk.com ↗ Novo Nordisk meddelte i dag, at det japanske ministerium for sundhed, arbejde og velfærd har godkendt Ryzodeg® (insulin degludec/insulin aspart) til behandling af diabetes.
2012-11-08	Novo Nordisk A/S	Regulatory Positiv afstemning i FDA's rådgivende komite vedrørende godkendelse af insulin degludec og insulin degludec/ insulin aspart novonordisk.com ↗ Bagsværd, den 9. november 2012 Novo Nordisk meddelte i dag, at Endocrinologic and Metabolic Drugs Advisory Committee, som er en rådgivende komite for de amerikanske sundhedsmyndigheder (FDA), har afsluttet sit møde vedrørende registreringsansøgningerne for insulin degludec og insulin degludec/insulin aspart.
2012-11-08	Novo Nordisk A/S	Regulatory Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval from FDA Advisory Committee novonordisk.com ↗
2012-10-25	Novo Nordisk A/S	Regulatory FDA discloses focus of Advisory Committee meeting on insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗ Novo Nordisk today announced that the US Food and Drug Administration (FDA) has published information pertaining to the focus of the Advisory Committee meeting scheduled for 8 November 2012 to discuss the New Drug Applications for insulin degludec and insulin degludec/insulin aspart.
2012-07-18	Novo Nordisk A/S	Regulatory Novo Nordisk A/S: FDA schedules Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗ an FDA Advisory Committee meeting is tentatively scheduled to be held on 8 November 2012 to discuss the New Drug Applications (NDA) for the ultra-long-acting insulin degludec and insulin degludec/insulin aspart.
2012-06-08	Novo Nordisk A/S	Regulatory Novo Nordisk A/S: FDA forlænger registreringssprocessen for insulin degludec og insulin degludec/insulin aspart med tre måneder novonordisk.com ↗ Novo Nordisk har i dag meddelt, at de amerikanske sundhedsmyndigheder (FDA) har forlænget registreringssprocessen for den ultralangtidsvirkende insulin degludec og insulin degludec/insulin aspart til behandling af type 1- og type 2-diabetes.
2012-06-08	Novo Nordisk A/S	Regulatory Novo Nordisk A/S: FDA extends regulatory review period for insulin degludec and insulin degludec/insulin aspart by three months novonordisk.com ↗ Novo Nordisk today announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for the ultra-long-acting insulins degludec and insulin degludec/insulin aspart for the treatment of type 1 and type 2 diabetes.

All press releases naming this drug 24 releases

Date	Issuer	Release
2025-08-28	Gan and Lee Pharmaceuticals, USA	Gan & Lee Pharmaceuticals' Preclinical Results of Novel Premixed Insulin GZR101 Published in Naunyn-Schmiedeberg's Archives of Pharmacology ganlee.com ↗
2015-09-25	Novo Nordisk A/S	Novo Nordisk får FDA-godkendelse for Tresiba® og Ryzodeg® 70/30 i USA novonordisk.com ↗
2015-04-07	Novo Nordisk A/S	Novo Nordisk A/S: Amerikanske FDA accepterer at behandle genindsendelserne af Tresiba® og Ryzodeg® novonordisk.com ↗
2015-04-07	Novo Nordisk A/S	US FDA accepts Tresiba® and Ryzodeg® resubmissions for review novonordisk.com ↗
2013-02-10	Novo Nordisk A/S	Novo Nordisk receives Complete Response Letter in the US for Tresiba® and Ryzodeg® novonordisk.com ↗
2013-02-10	Novo Nordisk A/S	Novo Nordisk modtager Complete Response Letter i USA vedrørende Tresiba® og Ryzodeg® novonordisk.com ↗
2013-01-21	Novo Nordisk A/S	Tresiba® (insulin degludec) og Ryzodeg® (insulin degludec/insulin aspart) får markedsføringstilladelse i Europa novonordisk.com ↗
2013-01-21	Novo Nordisk A/S	Tresiba® and Ryzodeg® receive marketing authorisations in Europe 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	Positiv afstemning i FDA's rådgivende komite vedrørende godkendelse af insulin degludec og insulin degludec/ insulin aspart 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 ↗
2012-07-18	Novo Nordisk A/S	Novo Nordisk A/S: FDA berammer møde i rådgivende komite om insulin degludec og insulin degludec/insulin aspart novonordisk.com ↗
2012-07-18	Novo Nordisk A/S	Novo Nordisk A/S: FDA schedules Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart novonordisk.com ↗
2012-06-08	Novo Nordisk A/S	Novo Nordisk A/S: FDA forlænger registreringssprocessen for insulin degludec og insulin degludec/insulin aspart med tre måneder novonordisk.com ↗
2012-06-08	Novo Nordisk A/S	Novo Nordisk A/S: FDA extends regulatory review period for insulin degludec and insulin degludec/insulin aspart by three months novonordisk.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

Field	Value	Cited text
Known as	insulin degludec/insulin aspart	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01138488 ↗
Known as	IDegAsp	“Insulin degludec/insulin aspart (IDegAsp) is a soluble coformulation of long-acting insulin degludec and short-acting insulin aspart.” PMID 26782928 ↗ Jan 2016
Known as	NN5401	“The aim of this study was to investigate the total exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult subjects with type 1 diabetes.” NCT01138488 ↗
Modality	Protein / enzyme biologic	“Insulin degludec/insulin aspart (IDegAsp) is a soluble coformulation of long-acting insulin degludec and short-acting insulin aspart.” PMID 26782928 ↗ Jan 2016
Route	Subcutaneous	“Insulin degludec/insulin aspart administered as a single subcutaneous injection (under the skin).” NCT01138488 ↗