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Clinical-Stage Companies / Amphastar

Amphastar

Pre-Approval PRO BETA
20
Total Trials
8
Phase 3
13
Phase 2
1
Recruiting
241
Score

Pipeline by Phase

Phase 3
8
Phase 2
13
Phase 1
4

Therapeutic Focus

Asthma Bronchospasm Pharmacokinetics Pharmacodynamics Insulin Aspart

Clinical Trials (20)

NCT01460511 Phase 3 COMPLETED

Evaluation of Efficacy and Safety of E004 in Children With Asthma

Started: 10/1/2011

NCT01476904 Phase 3 COMPLETED

Safety Study in Adolescent and Adult Patients With Asthma

Started: 11/1/2011

NCT01737905 Phase 3 COMPLETED

Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma

Started: 10/1/2012

NCT01357642 Phase 3 COMPLETED

Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients

Started: 7/1/2011

NCT00634517 Phase 3 TERMINATED

4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma

Started: 3/1/2008

NCT00634829 Phase 3 TERMINATED

Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction

Started: 2/1/2008

NCT07560150 Phase 2 RECRUITING

Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers

Started: 4/6/2026

NCT05539872 Phase 2 COMPLETED

Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers

Started: 8/22/2022

NCT01189396 Phase 2 COMPLETED

Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006

Started: 7/1/2010

NCT01581177 Phase 2 COMPLETED

Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation

Started: 4/1/2012

NCT02210806 Phase 2 COMPLETED

Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation

Started: 7/1/2014

NCT02271334 Phase 2 COMPLETED

Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers

Started: 8/1/2014

NCT01174732 Phase 2 COMPLETED

Dose-Ranging Study of A006 DPI, in Adult Asthma Patients

Started: 7/1/2010

NCT01689363 Phase 2 COMPLETED

Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)

Started: 9/1/2012

NCT01255709 Phase 2 COMPLETED

Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS

Started: 12/1/2010

NCT01143051 Phase 1 COMPLETED

Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers

Started: 1/1/2010

NCT01025648 Phase 1 TERMINATED

Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients.

Started: 12/1/2009

NCT01188577 Phase 1 COMPLETED

Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics

Started: 8/1/2010

NCT01737892 Phase 1 TERMINATED

Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults

Started: 11/1/2012

NCT04207840 Phase 4 COMPLETED

Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals

Started: 12/9/2019

Drug Candidates

I004 NovoLog epinephrine inhalation aerosol E004 (Epinephrine Inhalation Aerosol) HFA-MDI E004 (epinephrine inhalation aerosol), 90 mcg/actuation E004 (epinephrine inhalation aerosol), 125 mcg E004 (epinephrine inhalation aerosol), 220 mcg epinephrine inhalation aerosol, CFC propelled E004 (epinephrine inhalation aerosol), 160 mcg Epinephrine Inhalation Aerosol, HFA
Activity Status: Active
Last Trial Started: 4/6/2026
Last Trial Ended: 1/30/2023
Trials (12 months): 1
Completed Trials: 15
Data sourced from ClinicalTrials.gov. This company has no FDA-approved drugs.