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Tymlos (ABALOPARATIDE)

Radius · FDA-approved approved Recombinant protein Verified Quality 75/100

Tymlos works by mimicking the action of parathyroid hormone to stimulate bone growth and increase bone density.

Tymlos (abaloparatide) is a Parathyroid Hormone-Related Peptide Analog developed by Radius Health Inc. It targets the parathyroid hormone/parathyroid hormone-related peptide receptor to treat osteoporosis and prevent fractures in individuals at risk. Tymlos was FDA-approved in 2017 and remains a patented product with no generic manufacturers. Key safety considerations include potential increased risk of osteoporosis-related hypercalcemia. As a small molecule modality, Tymlos is administered via injection.

At a glance

Generic nameABALOPARATIDE
SponsorRadius
Drug classParathyroid Hormone-Related Peptide Analog [EPC]
TargetParathyroid hormone/parathyroid hormone-related peptide receptor
ModalityRecombinant protein
Therapeutic areaBone
PhaseFDA-approved
First approval2017

Mechanism of action

Abaloparatide is PTHrP(1-34) analog which acts as an agonist at the PTH1 receptor (PTH1R). This results in activation of the cAMP signaling pathway in target cells. Once-daily administration of abaloparatide stimulates new bone formation on trabecular and cortical bone surfaces by stimulation of osteoblastic activity. In rats and monkeys, abaloparatide had an anabolic effect on bone, demonstrated by increases in BMD and bone mineral content (BMC) that correlated with increases in bone strength at vertebral and/or nonvertebral sites [see Nonclinical Toxicology (13.2)].

Approved indications

Common side effects

Key clinical trials

Patents

PatentExpiryType

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
FDA Orange BookPatents + exclusivity