Head-to-head evidence
Afrezza vs ORMD-0801
Same mechanism, same race: design-graded trial evidence for both assets, with the grading rationale shown. Grades describe the quality of the evidence, never the merits of either security.
Type 2 Diabetes
Shared mechanism: Insulin receptor (basal) · full Type 2 Diabetes pipeline
Afrezza
Marketed by MannKind Corporation
NCT00332488 · Phase 3 · completed
The trial randomized 528 participants across three treatment groups and used an active comparator, but it was open-label rather than blinded and its primary endpoint was the surrogate measure HbA1c. The primary comparison was not met: HbA1c decreased by 0.70% with inhaled insulin plus metformin versus 0.78% with metformin plus secretagogue (p=0.420).
ORMD-0801
Developed by Oramed
NCT04606576 · Phase 3 · terminated
This is a large, randomized, fully blinded, placebo-controlled trial using blood sugar control (A1C), the standard disease-defining measure for diabetes, as its primary endpoint, a well-designed setup for showing a real treatment effect. Registry results were not posted at the time of grading; the key result shown was recovered from the cited external source.
Next expected readout: April 2027 · NCT06731075 (registry estimate)
The full competitive landscape for each asset (every same-race competitor with aligned evidence, sortable) is on the asset pages: Afrezza's landscape · ORMD-0801's landscape