Last reviewed · How we verify

Allogenic human purified pancreatic islets

National Institute of Allergy and Infectious Diseases (NIAID) · Phase 3 active Biologic

Allogenic human purified pancreatic islets is a Cell therapy Biologic drug developed by National Institute of Allergy and Infectious Diseases (NIAID). It is currently in Phase 3 development for Type 1 diabetes mellitus with severe hypoglycemia unawareness or brittle diabetes.

Allogenic human purified pancreatic islets restore insulin-producing beta cell function by transplanting functional islet cells into patients with type 1 diabetes.

Allogenic human purified pancreatic islets restore insulin-producing beta cell function by transplanting functional islet cells into patients with type 1 diabetes. Used for Type 1 diabetes mellitus with severe hypoglycemia unawareness or brittle diabetes.

At a glance

Generic nameAllogenic human purified pancreatic islets
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Drug classCell therapy
ModalityBiologic
Therapeutic areaEndocrinology / Diabetes
PhasePhase 3

Mechanism of action

This therapy involves isolation and purification of insulin-secreting islet cells from deceased human donors, which are then transplanted into patients with type 1 diabetes to restore endogenous insulin production. The transplanted islets engraft in the recipient and begin producing insulin in response to blood glucose levels, reducing or eliminating the need for exogenous insulin therapy. This approach aims to achieve better glycemic control and reduce hypoglycemic episodes compared to insulin injection alone.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Allogenic human purified pancreatic islets

What is Allogenic human purified pancreatic islets?

Allogenic human purified pancreatic islets is a Cell therapy drug developed by National Institute of Allergy and Infectious Diseases (NIAID), indicated for Type 1 diabetes mellitus with severe hypoglycemia unawareness or brittle diabetes.

How does Allogenic human purified pancreatic islets work?

Allogenic human purified pancreatic islets restore insulin-producing beta cell function by transplanting functional islet cells into patients with type 1 diabetes.

What is Allogenic human purified pancreatic islets used for?

Allogenic human purified pancreatic islets is indicated for Type 1 diabetes mellitus with severe hypoglycemia unawareness or brittle diabetes.

Who makes Allogenic human purified pancreatic islets?

Allogenic human purified pancreatic islets is developed by National Institute of Allergy and Infectious Diseases (NIAID) (see full National Institute of Allergy and Infectious Diseases (NIAID) pipeline at /company/national-institute-of-allergy-and-infectious-diseases-niaid).

What drug class is Allogenic human purified pancreatic islets in?

Allogenic human purified pancreatic islets belongs to the Cell therapy class. See all Cell therapy drugs at /class/cell-therapy.

What development phase is Allogenic human purified pancreatic islets in?

Allogenic human purified pancreatic islets is in Phase 3.

What are the side effects of Allogenic human purified pancreatic islets?

Common side effects of Allogenic human purified pancreatic islets include Graft rejection, Immunosuppression-related infections, Hypoglycemia, Hyperglycemia, Bleeding at transplant site.

Related