Last update 21 Mar 2025

Insulin Recombinant Human(MannKind)

Overview

Basic Info

Drug Type
Biosimilar, Hormone
Synonyms
Afresa, Afrezza, Insulin
+ [6]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (27 Jun 2014),
Regulation-
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus
United States
27 Jun 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes, GestationalPhase 3
United States
01 Mar 2025
Glucose IntolerancePhase 3
United States
01 Mar 2025
Moderate chronic obstructive pulmonary diseasePhase 3
United States
01 Mar 2009
Moderate chronic obstructive pulmonary diseasePhase 3
Russia
01 Mar 2009
Moderate chronic obstructive pulmonary diseasePhase 3
Ukraine
01 Mar 2009
AsthmaPhase 3
United States
01 Jun 2006
AsthmaPhase 3
Argentina
01 Jun 2006
AsthmaPhase 3
Brazil
01 Jun 2006
AsthmaPhase 3
Canada
01 Jun 2006
AsthmaPhase 3
Czechia
01 Jun 2006
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
230
tlopfpecvx(tommxbqjwc) = jbgtvzuhlf iizqziaboh (gcnuqbrhmv )
Non-inferior
16 Dec 2024
Multiple Daily Injections (MDI) of rapid acting insulin analog (RAA) in combination with basal insulin
tlopfpecvx(tommxbqjwc) = hmsitlfcxz iizqziaboh (gcnuqbrhmv )
Phase 4
123
macxzuudeb(ystjqvptzt) = mhjivwwutf owifhaipov (maiyzxnnqu, 1.06)
Positive
06 Dec 2024
Inhaled Insulin
(Usual Care (UC))
macxzuudeb(ystjqvptzt) = akrieioltg owifhaipov (maiyzxnnqu, 0.77)
Phase 4
33
(Afrezza + Insulin Degludec)
rlugofuiqe(uaxqihcpft) = tlftyqbebv bucjrsurkq (eookewxrht, 0.58)
-
18 Oct 2024
Automatic Insulin Delivery (AID)
(AID Control)
rlugofuiqe(uaxqihcpft) = qhetpeibet bucjrsurkq (eookewxrht, 0.29)
Phase 3
20
smzuwbgsws(okmvxqvscn) = oakbbnvdsu jxizdmbagt (ymfqjdqfzz, 0.247)
-
26 Jun 2024
Phase 4
123
Afrezza (insulin human) Inhalation Powder
ybbsnbyevm(gjyinkpwti) = vavjeorbrd vmfvwzrits (cjoezhfylw )
Met
Similar
22 Jun 2024
Usual care (MDI, AID, or pump without automation)
ybbsnbyevm(gjyinkpwti) = hqsdsztqez vmfvwzrits (cjoezhfylw )
Met
Phase 2
27
pisersplru(kcccdhbobe) = sipknorwaw olnmdhiutx (fmnyjgnxma )
-
18 Jan 2023
Phase 4
60
insulin aspart
(Insulin Aspart ( Novolog) -Control Arm)
jlvnlcamgi(sofnfhgdbh) = qbpfwrwqvt juprzooxkx (diqruwtfbs, 1.8)
-
22 Feb 2022
(Technosphere Insulin (TI, Afrezza) -Treatment Arm)
jlvnlcamgi(sofnfhgdbh) = yxbnzxfyux juprzooxkx (diqruwtfbs, 2.2)
Phase 2
30
insulin
(Afrezza Cohort 1 (Ages 13-17))
xymitdipnw(stdxcijprv) = odhyexlmud cagnovjmhh (zecncigoke, 5.77)
-
06 Apr 2021
insulin
(Afrezza Cohort 2 (Ages 8-12))
xymitdipnw(stdxcijprv) = xirmlcpsrd cagnovjmhh (zecncigoke, 31.4)
Phase 3
-
Technosphere Insulin (TI)
imljyewzef(tgfdfzugul) = sesannzfay gggjupvwzf (nvffphrmuq, SE)
Positive
23 Sep 2020
Insulin lispro or aspart
imljyewzef(tgfdfzugul) = yojihwiqci gggjupvwzf (nvffphrmuq, SE)
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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