Drug intelligence / Profile preview

TBRIA

Development stage
Phase 4
Lead developer
Tarsa Therapeutics
Modality
Small Molecules, Peptides, Recombinant Proteins and Enzymes
Administration
Oral
01

Overview

TBRIA is a once-daily oral tablet formulation of recombinant salmon calcitonin developed for the treatment of postmenopausal osteoporosis in women more than five years post-menopause when alternative treatments are not suitable. It represents the first potential FDA-approved oral form of calcitonin—a peptide hormone that inhibits bone resorption and promotes bone formation by osteoblasts. The drug acts as an agonist at the calcitonin receptor to reduce osteoclast activity and decrease bone turnover. TBRIA demonstrated positive safety and efficacy in a pivotal Phase 3 trial (ORACAL), showing statistical superiority over both placebo and nasal spray formulations in increasing lumbar spine bone mineral density after 48 weeks[2][3][6]. The product uses proprietary Peptelligence® oral delivery technology originally licensed from Enteris BioPharma (now MOD3 Pharma)[2][6].

Brand names
TBRIAOstora
Other names
Calcitonin-salmon [rDNA origin] delayed release tabletsOral recombinant salmon calcitoninSalmon calcitonin oral
02

Targets

CALCR (Calcitonin receptor)

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