Drug Profile

Human insulin biosimilar - PiSA Farmaceutica

Alternative Names: Insulex R

Latest Information Update: 07 Feb 2026

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At a glance

Originator PiSA Farmaceutica
Class Antihyperglycaemics; Hepatoprotectants; Insulins; Pancreatic hormones
Mechanism of Action Insulin receptor agonists; Ornithine decarboxylase stimulants; Phosphokinase stimulants; Protein tyrosine kinase stimulants

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Marketed Diabetes mellitus

Most Recent Events

04 Feb 2026 Phase-I clinical trials in Diabetes mellitus (In volunteers) in USA (SC) (NCT07364669)
07 May 2025 PiSA Farmaceutica completes a phase I trial in Diabetes mellitus in USA (SC) (NCT07364669)
26 Jan 2023 Launched for Diabetes mellitus in Mexico (SC)

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