Evidence Grade A — Regulatory approved. 377 published studies. 24 registered clinical trials.
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Abaloparatide (sold as Tymlos) is an injectable medication that actively builds new bone, prescribed for people at high risk of breaking bones due to osteoporosis. Unlike treatments that simply slow bone loss, abaloparatide stimulates the body to form new bone tissue, making bones stronger and denser. In a major clinical trial, it cut the risk of spinal fractures by 86% compared to a placebo over 18 months.
Abaloparatide is also known by these brand and alternate names:
377 published studies: 250 human, 40 animal, 17 in-vitro, 149 reviews
Abaloparatide is marketed as Tymlos (approved April 2017 for postmenopausal osteoporosis; December 2022 for male osteoporosis). In the ACTIVE trial, it reduced vertebral fractures by 86% and non-vertebral fractures by 43% compared to placebo over 18 months. Bone density gains at the hip were numerically greater than with teriparatide.
The ACTIVExtend follow-up study showed that patients who transitioned from abaloparatide to the anti-resorptive alendronate maintained their bone gains over an additional two years — the fracture reduction benefit persisted long after the bone-building treatment ended. Like teriparatide, treatment duration is limited to two years. Abaloparatide carries the same preclinical bone tumour warning as teriparatide, though a transdermal patch formulation is in development that could offer a needle-free alternative.
Abaloparatide targets the same receptor as teriparatide (the PTH1 receptor) but engages it differently. The receptor exists in two configurations — one linked to bone building and one linked to bone breakdown and calcium release. Abaloparatide was specifically designed to preferentially activate the bone-building configuration, producing a brief, transient signal that strongly stimulates new bone formation. This selective activation means it builds bone comparably to teriparatide but with less calcium elevation in the blood — a safety advantage.
Abaloparatide has strong clinical evidence from well-designed trials. The ACTIVE trial demonstrated an 86% reduction in vertebral fractures and a 43% reduction in non-vertebral fractures over 18 months, with bone density gains at the hip that were numerically better than those seen with the older bone-building drug teriparatide. A follow-up study (ACTIVExtend) showed that patients who transitioned to a standard anti-resorptive medication maintained their bone gains for at least two additional years. The main limitations are a two-year cap on treatment duration (shared with all drugs in this class) and a preclinical warning about bone tumours observed in animal studies. Direct head-to-head fracture data against teriparatide are limited — the comparison arm in the ACTIVE trial was not designed to detect differences between the two drugs. A transdermal patch version that could have eliminated the need for daily injections did not succeed in development.
PeptideTrace tracks 24 registered clinical trials for Abaloparatide sourced from ClinicalTrials.gov.
The Effect of Osteoporotic Medications on Vertebral Bone Quality Score
To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
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
Supracondylar Distal Femur Fractures and Abaloparatide
Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis
FDA ORIG 1
FDA SUPPL 1
FDA SUPPL 4
FDA SUPPL 3
FDA SUPPL 7
FDA SUPPL 9
FDA SUPPL 10
EMA Marketing Authorisation
FDA SUPPL 13
FDA SUPPL 15
FDA SUPPL 17
Abaloparatide is a 34-amino-acid synthetic analogue of parathyroid hormone-related protein, PTHrP(1-34), with 76% homology to PTHrP and 41% homology to PTH. It was designed to preferentially engage the RG conformation of PTH1R.
Abaloparatide binds PTH1R but preferentially stabilizes the RG (G-protein-coupled) receptor conformation rather than the R0 (uncoupled) conformation. RG-selective binding produces a brief, transient cAMP signal that favors bone formation (anabolic), while R0 binding (which teriparatide engages more) produces prolonged signaling that also stimulates bone resorption. This pharmacological distinction results in abaloparatide having a greater anabolic-to-resorptive ratio and less hypercalcemia than teriparatide.
Abaloparatide is marketed as Tymlos (approved April 28, 2017 for postmenopausal osteoporosis; December 19, 2022 for male osteoporosis). The ACTIVE trial (N=2,463; 18 months) demonstrated an 86% reduction in vertebral fractures (0.58% vs 4.22% placebo; P<0.0001) and a 43% reduction in nonvertebral fractures (P=0.04). Total hip BMD increased by 4.18% versus 3.26% for teriparatide (significantly greater). Hypercalcemia was lower with abaloparatide (3.4%) than teriparatide (6.4%; P=0.006). A transdermal patch formulation was in development but the Phase 3 wearABLe trial did not meet noninferiority, and the patch program was discontinued in June 2022.
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Linaclotide is marketed as Linzess (approved August 2012). It is taken as a daily oral capsule on an empty stomach, at least 30 minutes before the first meal. The recommended dose is 290 mcg for IBS-C and 72 or 145 mcg for chronic constipation. In clinical trials, approximately 34% of IBS-C patients met the composite improvement endpoint compared to 17% on placebo. Diarrhoea is the most common side effect (approximately 20%) and the leading reason for discontinuation. Linaclotide has a boxed warning against use in children under 6 years due to deaths in young mice, though no such events have been reported in humans. It competes with plecanatide (which targets the same pathway) and other IBS-C treatments.
Elamipretide (Forzinity) was approved by the FDA for Barth syndrome based on the TAZPOWER trial. The randomised crossover phase (12 patients) did not meet its primary endpoints, but the open-label extension (168 weeks) demonstrated durable improvements in walking distance and muscle strength that formed the basis for approval. Barth syndrome affects approximately 1 in 300,000–400,000 births. A larger Phase III trial in primary mitochondrial myopathy (218 patients, MMPOWER-3) did not meet its primary endpoint, and the drug was not approved for that broader indication. Elamipretide remains approved exclusively for Barth syndrome. See also SS-31 (#158) for the research compound context.
Glucagon has been available as an emergency injection since the 1960s and remains the standard rescue treatment for severe hypoglycaemia. Recent innovation has focused on making it easier to administer in emergencies. Baqsimi, approved in 2019, was the first needle-free option as a nasal powder. Gvoke, also approved in 2019, eliminated the need to mix and reconstitute the medication before injection — a significant advance since severe hypoglycaemia often impairs the ability to follow complex preparation steps. Dasiglucagon (Zegalogue), a next-generation stable liquid glucagon approved in 2021, further improved on the convenience of rescue administration. Beyond emergency rescue, glucagon's receptor is now a major research target — dual and triple agonists combining glucagon receptor activity with GLP-1 (such as survodutide and retatrutide) are in advanced clinical trials for obesity and metabolic disease.
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