Amphastar Pharmaceuticals

21 total trials 1 currently recruiting 15 completed

Amphastar Pharmaceuticals sponsors 21 registered US clinical trials on ClinicalTrials.gov, 1 of them currently recruiting, and 15 completed. 8 of these trials are in Phase 3-4 (later-stage) and 13 in Phase 1-2 (earlier-stage). The most-studied condition in this pipeline is Asthma, with 4 trials.

Trial Pipeline

21 total, page 1 of 1

RECRUITING Phase 2

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

NCT07560150

COMPLETED Phase 2

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

NCT05539872

COMPLETED Phase 4

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

NCT04207840

COMPLETED Phase 2

Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers

NCT02271334

COMPLETED Phase 2

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

NCT02210806

TERMINATED Phase 1

Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults

NCT01737892

COMPLETED Phase 3

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

NCT01737905

COMPLETED Phase 2

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

NCT01689363

COMPLETED Phase 2

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

NCT01581177

COMPLETED Phase 3

Safety Study in Adolescent and Adult Patients With Asthma

NCT01476904

COMPLETED Phase 3

Evaluation of Efficacy and Safety of E004 in Children With Asthma

NCT01460511

COMPLETED Phase 3

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

NCT01357642

COMPLETED Phase 2

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

NCT01255709

COMPLETED Phase 1

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

NCT01188577

COMPLETED Phase 2

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

NCT01174732

COMPLETED Phase 2

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

NCT01189396

COMPLETED Phase 1

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

NCT01143051

TERMINATED Phase 1

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

NCT01025648

TERMINATED Phase 3

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

NCT00634517

TERMINATED Phase 3

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

NCT00634829

TERMINATED Phase 3

Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients

NCT00635505

Phase Distribution

PhaseTrial count
Phase 1 4
Phase 2 9
Phase 3 7
Phase 4 1

What the Pipeline for Amphastar Pharmaceuticals Shows

According to the ClinicalTrials.gov registry, Amphastar Pharmaceuticals is linked to 21 US clinical trials across every stage of research activity. Of those, 1 studies are currently recruiting, about 5% of the sponsor's indexed portfolio, and 15 are already marked complete, representing roughly 71% of the total.

The phase mix for Amphastar Pharmaceuticals reports 8 late-stage studies (Phase 3 and Phase 4 combined) and 13 earlier-phase studies (Phase 1 and Phase 2).

The top therapeutic focus area indexed for Amphastar Pharmaceuticals is Asthma with 4 linked trials, and 4 other condition areas appear in the top list above.

How to read these pipeline numbers

Recruiting share is one of the more practical signals here: it reflects how much of a sponsor's research is presently open to new participants, while the completed share indicates the depth of finished work that has already contributed registry results. Both counts come directly from the public ClinicalTrials.gov dataset and are refreshed on the registry side; this page mirrors the latest data pull without altering it.

A portfolio weighted toward Phase 3 usually reflects an organization advancing candidates toward regulatory review, where the research centers on comparative efficacy and broader safety across larger populations. A heavier Phase 1 and Phase 2 tilt generally indicates exploratory work, safety, dosing, and early signal detection, and is common among research-forward sponsors that seed many early programs. Phase 4 entries, when present, track interventions already in real-world use and typically focus on long-term safety, effectiveness across subgroups, or formulation comparisons.

That distribution is a quick read of where the organization concentrates its research attention; it does not imply product availability, market share, or any clinical endorsement. All numbers on this page come from ClinicalTrials.gov maintained by the National Library of Medicine, and counts can shift as new studies are registered or existing ones update their status. This information is provided for reference and educational purposes only, not as medical, investment, or regulatory advice, verify current details directly with ClinicalTrials.gov before relying on any figure here.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial from this sponsor, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.