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teriparatide (SBL001 / Kauliv / SBL 001)

✓ Approved

Stelis Biopharma · PTH1R

What is teriparatide?

teriparatide is a therapeutic agent developed by Stelis Biopharma. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesSBL001, Kauliv, SBL 001
CompanyStelis Biopharma
Molecular TargetPTH1R
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Stelis Biopharma

Mechanism of Action

Molecular Targets

teriparatide acts on 1 molecular target:

PTH1Rparathyroid hormone 1 receptor (PTHR, EKNS)
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Therapeutic Indications

teriparatide is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Musculoskeletal and connective tissue disordersOsteoporosis✓ Approved

Related Research Articles

PubMedClinics in orthopedic surgery2026-10-15

Conservative Treatment with Adjunctive Use of Teriparatide for Periprosthetic Humeral Fractures after Reverse Total Shoulder Arthroplasty: A Report of 6 Cases.

Sohn Hyuk-Joon HJ, Park Bum-Soon BS, Hwang Junkyung J, Yoon Jong Pil JP et al.

Periprosthetic humeral fractures (PPHFs) after reverse total shoulder arthroplasty (RTSA) are challenging complications, particularly in elderly patients with osteoporotic bone and multiple comorbidities. Although surgical treatment is commonly recommended for displaced fractures, conservative management may be preferable in high-risk patients. This study reports 6 cases of PPHF after RTSA successfully treated with conservative management incorporating adjunctive teriparatide therapy. Six patients (mean age, 77.2 years; range, 70-87 years) who developed PPHF after RTSA were treated nonoperatively with daily subcutaneous teriparatide (20 µg) and immobilization using an abduction brace. The mean follow-up duration was 23.8 months (range, 12-36 months). Fractures were classified according to the Wright and Cofield classification system. Radiographic outcomes were assessed using serial plain radiographs. Clinical outcomes were evaluated using the visual analog scale (VAS) pain score, American Shoulder and Elbow Surgeons (ASES) score, and active range of motion. Fracture patterns included type A (n = 1), type B (n = 4), and type C (n = 1). Radiographic union was achieved in all patients (100%) at a mean of 2.7 months (range, 2-4 months). One patient developed malunion. At final follow-up, the mean VAS pain score was 2.2 and the mean ASES score was 69.8. No teriparatide-related adverse events were observed. Conservative management with adjunctive teriparatide therapy resulted in reliable radiographic union of PPHF following RTSA in selected patients. In addition to fracture classification, factors such as fracture displacement, angular deformity, implant stability, and patient-specific clinical characteristics should be carefully considered when determining treatment strategy. This approach may represent a viable alternative for elderly patients with substantial medical comorbidities in whom surgical treatment carries considerable risk.

PMID 42876896
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PubMedDrug design, development and therapy2026-10-15

Managing Rebound Bone Loss After Denosumab Discontinuation: Mechanisms, Risk Stratification, and Sequential Therapy.

Ahmad, Liao Yuting Y, Yu Mei M, Xu Jiamei J et al.

Denosumab is a fully human monoclonal antibody targets receptor activator of nuclear factor kappa-Β ligand (RANKL), potently suppresses bone resorption, increases bone mineral density (BMD), and reduces vertebral, hip, and non-vertebral fracture risk. However, its pharmacokinetic reversibility renders discontinuation clinically hazardous. This narrative review synthesizes current evidence on the mechanisms, clinical consequences, and risk determinants of rebound bone loss following denosumab discontinuation and critically evaluates available preventive strategies. Upon denosumab cessation, rapid restoration of RANKL bioavailability triggers a pathological osteoclast overshoot, driven by accumulated osteoclast precursors and unopposed RANK-RANKL signaling. The resulting rebound in bone turnover produces accelerated BMD loss and markedly elevated multiple vertebral fracture risk, with real-world cohorts documenting incidences of up to 10% within 12-18 months of unmanaged cessation, and hip and vertebral fractures in this setting have been associated with substantial excess mortality in observational studies. Sequential antiresorptive therapy, principally intravenous zoledronic acid or oral alendronate, is the most widely recommended approach; risedronate consistently fails to provide adequate skeletal protection. Treatment duration critically modulates rebound severity, with longer denosumab therapy, particularly beyond approximately three years is associated with greater post-discontinuation bone loss and reduced protection from a single bisphosphonate infusion, warranting intensified monitoring and management in this group. Anabolic agents, including teriparatide, are generally not recommended as primary sequential therapy, whereas romosozumab is promising only when initiated early in carefully selected patients. Serial serum C-terminal telopeptide (CTX) monitoring provides a practical framework for guiding therapeutic transitions and identifying inadequate bone turnover suppression. Safe denosumab management requires structured, individualized planning that integrates risk stratification, biochemical monitoring, and a pre-defined sequential therapy strategy established at the time of prescription, not at the point of cessation.

PMID 42877773
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PubMedFrontiers in endocrinology2026-10-14

Case Report: Atypical femoral fractures in adult-onset hypophosphatasia treated with low-dose asfotase alfa and adjunctive teriparatide therapy.

Chung Yoon-Sok YS, Kim Kwang-Kyoun KK, S Gokul B GB, Park Ji-Seong JS

Hypophosphatasia is a rare inherited metabolic bone disease caused by low activity of tissue-nonspecific alkaline phosphatase. Adult-onset hypophosphatasia is increasingly recognized, but fracture patterns and optimal management remain unclear. We report a 52-year-old woman who presented with progressive pain and bilateral atypical femoral fractures. She was diagnosed with hypophosphatasia based on low alkaline phosphatase, markedly elevated pyridoxal 5'-phosphate, a history of metatarsal fracture, premature tooth loss, and pathogenic ALPL variants. Low-dose asfotase alfa was started because standard-dose therapy was not feasible. After 6 months, callus formation was observed, and pain improved. However, 6 months later, the pain recurred, and radiographs showed a progressive fracture, suggesting insufficient fracture healing. Staged intramedullary fixation was performed for both femurs. Two perioperative femoral fractures occurred during the course of surgical management. Therefore, adjunctive teriparatide (20 µg daily for six months) was initiated while continuing low-dose asfotase alfa. At 5-year follow-up, radiographic union of all femoral fractures was achieved, and the patient remained ambulatory without assistance and had no fracture-related pain. This case shows that adult-onset hypophosphatasia can cause severe skeletal fragility and may require individualized multidisciplinary management, including biochemical diagnosis, long-term radiographic surveillance, cautious surgical planning, and selective use of medication.

PMID 42871899
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PubMedHealth science reports2026-10-06

Effectiveness and Safety of Pharmacological Therapy for Osteoporosis in Frail Elderly Individuals: Systematic Review and Meta-Analysis.

Freire Anna Julia Lacerda Raposo AJLR, Gazoni Fernanda Martins FM, Carvalho Eduardo de Holanda EH, Santos Fânia Cristina FC

Frailty and osteoporosis are interrelated conditions that predominantly affect older adults. The greater the individual's frailty, the greater the probability of suffering a fracture and the greater the risk of fractures occurring in the future. Therefore, this study aimed to verify whether anti-fracture pharmacological therapies in frail individuals with osteoporosis are effective and safe. A systematic review of the literature was conducted using randomized clinical trials and observational studies. Participants aged 60 years or older, living in the community or in a long-term care facility, diagnosed with frailty and osteoporosis and with a history of anti-fracture medication use were evaluated. A meta-analysis was performed when appropriate. This review was conducted and reported following the PRISMA 2020 guidelines. Six studies with 42,851 frail elderly were included. Five were conducted in long-term care facilities (3 observational and 2 randomized clinical trials) and 1 observational study included community-dwelling elderly after hospitalization due to fragility fracture. All studies assessed fractures; four evaluated mortality, and one assessed bone mineral density. Three studies compared bisphosphonates to a non-antiosteoporotic treatment; one compared bisphosphonate, denosumab, and teriparatide to placebo; one compared denosumab and zoledronic acid to teriparatide; and one compared sequential teriparatide with alendronate to alendronate. Meta-analysis pointed to a potential reduction in hip fracture risk and mortality with bisphosphonates in institutionalized frail elderly. It also demonstrated that bisphosphonates can be safe with limited nonserious side effects. The findings suggest a possible benefit of pharmacological treatment in reducing hip fractures and mortality in frail elderly. The real impact of the anti-fracture therapies on those individuals still needs to be better studied.

PMID 42835888
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PubMedJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2026-10-06

Treatment of male osteoporosis: a narrative review and position statement by the ECTS Clinical Action Group.

Sølling Anne Sophie AS, Paccou Julien J, Anastasilakis Athanasios D AD, Reid Ian R IR et al.

Osteoporosis in men is under-recognized and under-treated despite a substantial disease burden and poorer fracture-related outcomes than in women. Secondary osteoporosis is highly prevalent in men, making the identification and management of underlying causes essential. Bone mineral density (BMD) and fracture risk are influenced by sex-specific patterns of skeletal growth and age-related bone loss, with men typically exhibiting greater cortical thickness, larger bone size, and trabecular thinning rather than loss of trabecular number. Although randomized controlled trials in men are fewer than in postmenopausal women, bisphosphonates, denosumab, teriparatide, abaloparatide, and romosozumab have all been shown to significantly increase BMD. Fracture outcome data remain limited; however, reductions in vertebral fracture risk have been demonstrated for zoledronate, alendronate, risedronate, denosumab, and teriparatide. Treatment should be individualized according to fracture risk, comorbidities, and patient preferences. In men at very high fracture risk, osteoanabolic therapy should be considered as first-line treatment, followed by antiresorptive therapy to consolidate and maintain BMD gains. Goal-directed (treat-to-target) management, including long-term maintenance therapy, and careful discontinuation strategies, particularly following denosumab, is essential for optimizing long-term skeletal health. This narrative review and position statement by The ECTS Clinical Action Group provides an updated overview of current and emerging treatment options and offers practical, evidence-based recommendations for the long-term management of osteoporosis in men.

PMID 42836541
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PubMedBone2026-10-04

Bone response to intermittent parathyroid hormone (PTH) is both genetic and sex specific in mice.

Adams Douglas J DJ, Godfrey Dana A DA, Ridoux Shane E SE, Maynard Robert D RD et al.

Teriparatide (PTH 1-34) is an anabolic agent used to treat osteoporosis, yet clinical response varies widely among patients. To investigate genetic and sex-specific determinants of skeletal response, we administered intermittent PTH to male and female mice from eight genetically diverse inbred strains. Mice were treated for four weeks, and bone phenotypes were assessed via DXA, microCT, and mechanical testing. Response to PTH was highly strain- and sex-dependent, with some strains responding at the femur but not the spine, and vice versa. Heritability estimates for PTH-induced changes in areal bone mineral density (aBMD), cortical bone area at the femoral mid-diaphysis, femur strength, and trabecular bone volume fraction (BV/TV) ranged from moderate to high, with BV/TV showing the strongest genetic influence. Cortical bone response mechanisms differed by sex: males exhibited periosteal expansion, while females showed endosteal remodeling. These findings mirror clinical observations where non-response to PTH can be anatomic site specific. Further, our study suggests that genetic background and sex significantly influence bone response to PTH. Our data support the future use of genetically diverse mouse models to elucidate the genetic architecture of skeletal response to PTH.

PMID 42829196
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