Last update 31 May 2025

Dance-501(Dance Biopharm Holdings, Inc.)

Overview

Basic Info

Drug Type
Hormone
Synonyms
Insulin inhalation, AER-501, DANCE 501
+ [2]
Target
INSR
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Therapeutic Areas
Immune System DiseasesEndocrinology and Metabolic Disease
Active Indication
Diabetes Mellitus, Type 1
Inactive Indication
AsthmaDiabetes Mellitus, Type 2Pulmonary Disease, Chronic Obstructive
Originator Organization
Aerami Therapeutics, Inc.
Active Organization
Hikma Pharmaceuticals PlcHikma Pharmaceuticals Plc
Inactive Organization
Aerami Therapeutics, Inc.
License Organization-
Drug Highest PhasePhase 2
First Approval Date-
Regulation-
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Related

5
Clinical Trials associated with Dance-501(Dance Biopharm Holdings, Inc.)
EUCTR2015-003672-76-DE
/ Not yet recruitingPhase 2
A Randomized, Open-Label, 6-Period Cross-Over Study to Investigate the Dose Response of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Subjects with Type 1 Diabetes Mellitus (T1DM)
EUCTR2015-003737-95-DE
/ Not yet recruitingPhase 2
A Randomized, Open-Label, 4-Period Cross-Over Study to Investigate the Inter- and Intra-subject Variability of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Subjects with Type 1 Diabetes Mellitus (T1DM)
NCT04100473
/ CompletedPhase 2
A Randomized, Open-Label, 6-Period Cross-Over Study to Investigate the Dose Response of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Subjects With Type 2 Diabetes Mellitus (T2DM)
100 Clinical Results associated with Dance-501(Dance Biopharm Holdings, Inc.)
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100 Translational Medicine associated with Dance-501(Dance Biopharm Holdings, Inc.)
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100 Patents (Medical) associated with Dance-501(Dance Biopharm Holdings, Inc.)
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100 Deals associated with Dance-501(Dance Biopharm Holdings, Inc.)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2Phase 2
Germany
Aerami Therapeutics, Inc.
23 Apr 2018
AsthmaPhase 2
United States
Aerami Therapeutics, Inc.
06 Feb 2018
Diabetes MellitusPhase 2
United States
Aerami Therapeutics, Inc.
06 Feb 2018
Pulmonary Disease, Chronic ObstructivePhase 2
United States
Aerami Therapeutics, Inc.
06 Feb 2018
Diabetes Mellitus, Type 1Phase 2-
Hikma Pharmaceuticals PlcHikma Pharmaceuticals Plc
-
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Clinical Result

Indication
Phase
Evaluation
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Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

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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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