Drug research

I004

Open a linked trial to see its study details and recorded changes, or check the regulatory events below and follow their sources.

Drug identity checked against registry records

Also recorded as Insulin Aspart, a rapid-acting human insulin analogue

A drug appearing in a clinical trial does not mean it is FDA-approved. Check the original regulatory source for any approval claim.

Included trials

Trial	Sponsor	Phase	Status	Primary completion
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 VolunteersNCT05539872	AMPH	Phase 2, Phase 3	Completed	2023-01-29Actual
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 VolunteersNCT07560150	AMPH	Phase 2, Phase 3	Completed	2026-06-22Actual

AMPHCompletedPrimary completion: 2023-01-29 · Actual

Trial details

AMPHCompletedPrimary completion: 2026-06-22 · Actual

Trial details

No regulatory events match this view.Try another date range or view. Events appear after automated source checks. This does not mean no FDA events have occurred. Dates that a source does not disclose stay undisclosed.