Last reviewed · How we verify
Tymlos (ABALOPARATIDE)
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 name | ABALOPARATIDE |
|---|---|
| Sponsor | Radius |
| Drug class | Parathyroid Hormone-Related Peptide Analog [EPC] |
| Target | Parathyroid hormone/parathyroid hormone-related peptide receptor |
| Modality | Recombinant protein |
| Therapeutic area | Bone |
| Phase | FDA-approved |
| First approval | 2017 |
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
- At risk of osteoporotic fracture
- Osteoporosis
Common side effects
- Hypercalciuria
- Dizziness
- Nausea
- Headache
- Palpitations
- Fatigue
- Upper abdominal pain
- Vertigo
- Orthostatic Hypotension
- Tachycardia
- Injection site redness
- Edema
Key clinical trials
- Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery (PHASE2)
- Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone (PHASE4)
- Sequential Therapies After Osteoanabolic Treatment
- Abaloparatide Before Total Knee Arthroplasty (PHASE4)
- To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture (PHASE3)
- A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide Injection and the Reference Formulation Abalparatide Injection (Tymlos®) in Healthy Adult Subjects (PHASE1)
- PTH Analog Type II Odontoid Fracture (PHASE2)
- Abaloparatide and Pelvic Fracture Healing (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |