ExeGen CLN3 miniswine

Manufacturer: Exemplar Genetics LLC (dba Precigen Exemplar)
Effective date: 2025-05-21
Label type: INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 02:51:38

Label at a glance#

ProductExeGen CLN3 miniswine

Active ingredientCLN3 RDNA CONSTRUCT DISRUPTING EXON 7 AND EXON 8 OF CLN3 GENE IN YUCATAN MINIATURE SWINE

Label structure1 sections

Contacts and useful links#

PhoneLabel contact712-722-2767

PhoneLabel contact712-441-3408

Label contents#

Full prescribing information#

ExeGen CLN3 miniswine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ExeGen CLN3 miniswine are genetically engineered yucatan miniature swine containing the rDNA construct pCLN3-Neo Excised which exhibit similar phenotypes to human patients with CLN3 disease. These pigs are intended to be used as large animal models of the human disease. We will not be requesting a food use authorization and the carcasses and all materials generated from these animals will be destroyed by incineration.

Product Definition: A specific line of Yucatan miniature pigs (Sus scrofa domesticus), including homozygous offspring resulting from a heterozygous founder, in which the CLN3 gene has been disrupted by the homologous recombination of a single copy of a mutated CLN3-PGK construct for use in biomedical research. The desirable animal will be a homozygote CLN3 Ex7-8del Neo Excised/Ex7-8del Neo Excised miniswine.

Warning: This product is from a genetically engineered animal and may contain an investigational new animal drug. It is for research purposes only and not for use in humans or as food/feed unless authorization has been granted by the US Food and Drug Administration. In case of emergency or release contact Exemplar Genetics at 712-722-2767 or 712-441-3408.

warning label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
86093-2001-1	ExeGen CLN3 miniswine	1 [arb'U] in 1 PACKAGE	NOT APPLICABLE	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
86093-2001	EXEGEN CLN3 MINISWINE (PCLN3-NEO EXCISED) NOT APPLICABLE [EXEMPLAR GENETICS LLC (DBA PRECIGEN EXEMPLAR)]	3	1 package rows	20250523_20512e4e-c3ff-4025-be18-c634c3b6a49d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

ExeGen CLN3 miniswine
pCLN3-Neo Excised
CLN3 RDNA CONSTRUCT DISRUPTING EXON 7 AND EXON 8 OF CLN3 GENE IN YUCATAN MINIATURE SWINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
86093-2001	86093-2001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CLN3 RDNA CONSTRUCT DISRUPTING EXON 7 AND EXON 8 OF CLN3 GENE IN YUCATAN MINIATURE SWINE	E3SP91Q3EF	ACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.