Identification
- Summary
Donislecel is an allogeneic pancreatic islets cellular therapy indicated for the treatment of type 1 diabetes
- Brand Names
- Lantidra
- Generic Name
- Donislecel
- DrugBank Accession Number
- DB17961
- Background
Donislecel is the first allogeneic pancreatic islet cellular from deceased donor pancreatic cells used for the treatment of adult type 1 diabetes with unsuccessful control of glycated hemoglobin, despite intensive diabetes management and treatments.1,2 The primary mechanism of action of donislecel is attributed to the secretion of insulin and other pancreatic hormones from infused allogeneic islet cells to mimic endogenous glucose control and homeostasis.1,2 The approval of donislecel was based on the safety and effectiveness evaluated in 2 clinical trials with 30 type 1 diabetic patients.2 Overall, 21 patients achieved insulin independence for a year or more, with 11 patients not needing insulin for 1 to 5 years and 10 patients for more than 5 years.2 Donislecel is particularly beneficial for type 1 diabetic patients with hypoglycemia unawareness, the inability to detect blood glucose dropping and thus unable to prevent further hypoglycemia, by not relying on exogenous and intentional insulin administration to control blood glucose.2
Donislecel was approved by the FDA on June 28, 2023, and is available under the brand name LANTIDRA from CellTrans Inc.2
- Type
- Biotech
- Groups
- Approved
- Synonyms
- Not Available
Pharmacology
- Indication
Donislecel-jujn is an allogeneic pancreatic islet cellular therapy indicated for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Use donislecel-jujn in conjunction with concomitant immunosuppression.1
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Used in combination to treat Type 1 diabetes mellitus •••••••••••• ••••• •••••••••• •••••••• •• •••••••••••• ••••••• •••••••• - Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- Pharmacodynamics
The pharmacodynamic effects of LANTIDRA are a result of hormones, especially insulin, that are secreted by the infused (transplanted) islets in response to fluctuations in blood glucose levels. Basal and stimulated blood glucose were determined at baseline and at 1 year following a subject’s last transplant during Study 1 and Study 2 using a mixed meal tolerance test (MMTT). The basal and 90-minute baseline glucose (mean+SD) were calculated to be 178 ± 76 and 357 ± 91 mg/dl respectively, while the basal and 90-minute 1-year Glucose were reported to be 106 ± 17 and 142 ± 40 mg/dl respectively.1
The pharmacodynamic profile of the allogeneic islet cells is most clearly demonstrated in subjects who are free from the requirement of exogenous insulin.1
- Mechanism of action
As donislecel-jujn is a pancreatic islet cellular therapy, its mechanism of action stems from the secretion of insulin by the β- cells in the transplanted islet cells.1
Pancreatic islets regulate blood glucose levels through the secretion of multiple hormones in response to increases or decreases in blood glucose. Endocrine cells within pancreatic islets release insulin, glucagon, somatostatin, pancreatic peptide, and ghrelin. Insulin stimulates glucose uptake by peripheral tissues; glucagon mobilizes glucose from the liver into circulation; somatostatin inhibits both α- and β-cell secretions; pancreatic peptide inhibits pancreatic exocrine secretion, and ghrelin inhibits insulin secretion.1
- Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
Not Available
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- Not Available
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Lantidra Solution 5000 [arb'U]/400mL Intravascular CellTrans Inc. 2023-06-28 Not applicable US 
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- Not Available
- CAS number
- Not Available
References
- General References
- External Links
- 2642217
- Wikipedia
- Donislecel
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count Not Available Approved for Marketing Not Available Type 1 Diabetes Mellitus 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Solution Intravascular 5000 [arb'U]/400mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
Drug created at June 30, 2023 21:45 / Updated at August 01, 2023 19:26