
Abaloparatide dosage
Dosing as the FDA label states it, how long trials ran, and the arithmetic for working with vials.
- Regulatory status
- FDA-approved
- Human amounts
- 80 micrograms once daily
- Route studied
- Subcutaneous injection
- Frequency
- Once daily
- Half-life
- Approximately 1 hour
- Evidence grade
- Grade A · Human trial evidence
- Vial sizes on the market
- Not recorded
- Other forms seen
- —
What Abaloparatide is
Abaloparatide is a synthetic 34-amino-acid analog of parathyroid hormone-related peptide, FDA-approved in 2017 as Tymlos for osteoporosis at high fracture risk in postmenopausal women and, to increase bone density, in men.
Abaloparatide acts as an agonist at the PTH1 receptor (PTH1R), activating cAMP signaling in target cells 1. Bone effects Once-daily administration stimulates new bone formation on trabecular and cortical surfaces through osteoblastic activity 1. In rats and monkeys it increased BMD and bone mineral content, correlating with bone strength 1. In postmenopausal women, the formation marker sPINP peaked at 93% above… How it works →
Key evidence
- Miller et al., JAMA (ACTIVE, NCT01343004) · 2016 · Humans (2,463 postmenopausal women with osteoporosis)New vertebral fractures lower than placebo; nonvertebral fracture event rate lower; hypercalcemia 3.4% versus 6.4% with teriparatide 2. 2
- Tymlos prescribing information, Section 14.1 (Studies 003 and 005) · 2026 · Humans (postmenopausal women; mITT 690 vs 711)
- Czerwinski et al., J Bone Miner Res (ATOM, NCT03512262) · 2022 · Humans (228 men aged 40-85 with osteoporosis)
Schedules by time period
Label regimens and laid out week by week. Each bar is what the label states or what investigators gave participants; none is a recommendation.
Tymlos (FDA label): dosing 1
Postmenopausal women and men with osteoporosis at high fracture risk · 104 weeks
Week-by-week table
| Period | Amount |
|---|---|
| Weeks 0–onward | 80 mcg (maintenance) |
Single fixed dosage; no escalation.
Lifetime use beyond 2 years is not recommended.
Dosing as stated on the FDA label
- The recommended dosage is 80 micrograms subcutaneously once daily, with supplemental calcium and vitamin D if dietary intake is inadequate 1.
- Safety and efficacy have not been evaluated beyond 2 years; use for more than 2 years during a patient's lifetime is not recommended 1.
- Do not administer intravenously or intramuscularly; give the first several doses where the patient can sit or lie down. Other administration instructions are in the label and are not reproduced here 1.
How long did human studies run?
No human study durations are recorded for Abaloparatide.
Cycle-length evidence for AbaloparatideSide effects reported in studies
- Hypercalciuria11% versus 9% placebo · Postmenopausal women, 18-month trial (n=822 vs 820) 1
- Dizziness10% versus 6% · Same trial 1
- Nausea8% versus 3% · Same trial 1
- Headache8% versus 6% · Same trial 1
- Palpitations5% versus 0.4% · Same trial 1
- Injection site redness58% versus 28% · Daily assessment during the first month 1
- Hypercalcemia (corrected calcium 10.7 mg/dL or higher at 4 hours)3% versus 0.1% · Postmenopausal women trial 1
- Elevated serum uric acid25% versus 6% with at least one value above normal · Patients with normal baseline uric acid 1
Supplies and handling
- Lyophilized vialSealed vial with the freeze-dried cake. Check the label, lot and the certificate of analysis before opening.
- Sterile diluentThe diluent named on the product documentation. Bacteriostatic water contains benzyl alcohol; sterile water does not.
- Graduated syringesSized to the volume being measured. U-100 insulin syringes are graduated in units where 100 units = 1 mL.
- Alcohol prep padsFor wiping vial stoppers before each puncture.
- Nitrile glovesClean gloves for aseptic handling.
- Sharps containerPuncture-resistant container for used needles.
Storage
The label directs refrigerated storage (2-8°C) before first use; after first use, up to 30 days at 20-25°C; do not freeze or expose to heat 1.
- Lyophilized (unmixed) vials: typically stored cold and dry, away from light, as the documentation directs. Many are stable longer frozen.
- Reconstituted vials: typically refrigerated (about 2–8 °C), protected from light and not frozen.
- Bacteriostatic water contains benzyl alcohol, which inhibits bacterial growth in multi-use vials; sterile water has no preservative.
Handling mistakes and troubleshooting
- Added the wrong volume of diluent
- The concentration changes, not the amount of compound in the vial. Recalculate with the volume actually added and relabel the vial.
- Shook the vial and it foamed
- Let it settle in the refrigerator. Foam is a sign of agitation; some peptides aggregate when shaken. Note it on the label.
- The solution is cloudy or has particles
- Do not use it. Cloudiness can indicate incomplete dissolution, contamination or degradation. Record the lot and contact the supplier with the certificate of analysis.
- The powder cake looks melted or shrunken before reconstitution
- This can indicate the vial was exposed to heat or moisture. Record the lot and condition on arrival.
- Liquid sprayed back when the needle was removed
- Pressure built up in the vial. Withdraw a small volume of air while adding diluent to keep pressure neutral.
Regulatory status
- Status
- FDA-approved (initial U.S. approval 2017) as Tymlos, NDA 208743, listed with prescription marketing status as of 2026-10-24 1,4.
- United States (FDA)
- FDA-approved (initial U.S. approval 2017) as Tymlos, NDA 208743, with prescription marketing status per Drugs@FDA as of 2026-10-24 1,4.
- Sport (WADA)
- Parathyroid hormone and PTHrP analogs, including abaloparatide, were not mentioned on the WADA 2026 Prohibited List page reviewed 5.
Status varies by country and changes over time. How we describe regulatory status.
Abaloparatide compared with related compounds
| Compound | Status | Evidence | Human amounts | Half-life |
|---|---|---|---|---|
| Abaloparatide | FDA-approved | A | FDA label | Approximately 1 hour |
| PEA | Not approved — research use only | A | None established | — |
| Vesugen | Not approved — research use only | C | None established | — |
| Kisspeptin-54 | Not approved — research use only | B | None established | About 28 minutes (intravenous, healthy m |
| Apelin-13 | Not approved — research use only | B | None established | Not located as a numeric value in the so |
| hCG (human chorionic gonadotropin) | FDA-approved | A | FDA label | About 29 hours (recombinant hCG, subcuta |
Frequently asked questions
What doses of Abaloparatide have been studied in humans?
Is there an established Abaloparatide cycle length?
How much bacteriostatic water should be added to a Abaloparatide vial?
How many units is a given amount on an insulin syringe?
What is the half-life of Abaloparatide?
References
- TYMLOS (abaloparatide) injection, for subcutaneous use, prescribing information (DailyMed, effective 08/2026) FDA label (DailyMed). 2026
- Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial (ACTIVE) JAMA. 2016
- The Efficacy and Safety of Abaloparatide-SC in Men With Osteoporosis: A Randomized Clinical Trial (ATOM) J Bone Miner Res. 2022
- Drugs@FDA (openFDA) application record NDA 208743, TYMLOS U.S. FDA. 2026
- World Anti-Doping Agency Prohibited List 2026 (online version) WADA. 2026
- PubChem compound record for abaloparatide PubChem. 2026
Last reviewed October 24, 2026 by the Amiravo editorial team. Editorial policy · Report an error