TYMLOS (abaloparatide)
Tymlos helps postmenopausal women and men with osteoporosis who are at a high risk for bone fractures. It is typically used for patients with a history of fractures, multiple risk factors, or those who have not responded well to other osteoporosis therapies. This medication works to increase bone density and reduce the likelihood of both vertebral and nonvertebral fractures.
How TYMLOS Works
This drug works by binding to the PTH1 receptor, which triggers a specific signaling pathway that stimulates osteoblastic activity. Daily use of the medication promotes the formation of new bone on both trabecular and cortical surfaces. This increase in bone mineral density and content helps improve overall bone strength.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-04-28
- Patent Cliff
- 2040
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
TYMLOS Approval History
What TYMLOS Treats
1 indicationsTYMLOS is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoporosis
TYMLOS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TYMLOS
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03841058 FAST-Healing | 2018-0287 | Ph 2 | active not recruiting | Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery |
| NCT04467983 | 2022-1296 | Ph 4 | active not recruiting | Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone |
| NCT04167163 | 2019-0685 A534255, SMPH/MEDICINE/MEDICINE*G | Ph 4 | completed | Abaloparatide Before Total Knee Arthroplasty |
| NCT04760782 results posted | STUDY00001025 | Ph 2 | terminated | PTH Analog Type II Odontoid Fracture |
| NCT04626141 | 2020-0544 | Ph 4 | withdrawn | Supracondylar Distal Femur Fractures and Abaloparatide |
| NCT03512262 results posted | BA058-05-019 ATOM | Ph 3 | completed | Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM) |
| NCT03746041 | 00003054 | Ph 1 | completed | A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes |
| NCT03710889 results posted | BA058-05-020 | Ph 3 | completed | Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption |
| NCT03708926 | IRB00185784 | Ph 2 | withdrawn | Effect of Abaloparatide on Lumbar Disc Degeneration |
| NCT07587775 | 20254288 | Ph 2 | not yet recruiting | The Effect of Osteoporotic Medications on Vertebral Bone Quality Score |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TYMLOS FDA Label Details
Indications & Usage
FDA Label (PDF)TYMLOS is indicated for the treatment of Osteoporosis.
TYMLOS Patents & Exclusivity
Patents (9 active)
Pro Intelligence Preview
Deep insights for TYMLOS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 12 active patents
Trial Analysis
- • 9 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment