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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)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

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

Therapeutic AreaConditionPhase
Musculoskeletal and connective tissue disordersOsteoporosis✓ Approved

Related Research Articles

PubMedPharmacological reports : PR2026-09-18

Is teriparatide linked to osteosarcoma? A disproportionality analysis of the FAERS database.

Balzano Nunzia N, Di Napoli Raffaella R, Laino Ludovica Vittoria LV, Ruggiero Rosanna R et al.

Teriparatide is approved for the treatment of osteoporosis and is generally well-tolerated. However, concerns remain about a possible association with osteosarcoma, a rare but aggressive bone malignancy. This pharmacovigilance study aims to evaluate the reporting frequency of osteosarcoma associated with teriparatide in the Food and Drug Administration Adverse Event Reporting System (FAERS). Individual case safety reports (ICSRs) listing teriparatide as a suspected drug and osteosarcoma as an adverse event were extracted from the FAERS public dashboard up to 20 February 2025. Both descriptive and disproportionality analyses were performed. A total of 112,798 ICSRs involving teriparatide were retrieved, of which 29 were reported. Most cases involved female patients (72.4%) and older patients (48.3%). Almost all reports (96.6%) were classified as serious, with death being the most common outcome (44.8%). Of the reports with information on concomitant medications, 31% included five or more medications, with vitamins being the most common. The disproportionality analysis showed a significantly higher reporting frequency of osteosarcoma with teriparatide compared to all other drugs (reporting odds ratio, ROR: 15.31; 95% CI: 10.53-22.26). This signal remained consistent when the analysis was restricted to reports submitted since 2006 (ROR: 15.88; 95% CI: 10.92-23.09). The information component (IC) analysis confirmed this finding (IC: 3.56; 95% CI: 2.95-4), and similar results were observed for the post-2006 subset (IC: 3.60; 95% CI: 2.99-4.05). However, the analysis compared to another osteoporosis drug (romosozumab) did not confirm any safety signal for teriparatide. This study highlights a disproportionate signal between teriparatide use and osteosarcoma when compared to all other drugs but not compared to romosozumab. Based on this and considering that previous evidence did not support an increased risk, further research is warranted to better understand this association.

PMID 42754773
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PubMedMediterranean journal of rheumatology2026-09-18

Cardiovascular Safety Signals of Osteoporosis Therapies: A FAERS Pharmacovigilance Study.

Sondhi Manush M, Singh Namrata N, Carkin Julie J, Hughes Grant G

To evaluate the associations between commonly used osteoporosis medications and major adverse cardiovascular events (MACE) using data from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). We conducted a retrospective pharmacovigilance analysis of FAERS reports between January 2019 and December 2024, identifying all reports involving alendronate, risedronate, zoledronic acid, denosumab, teriparatide, abaloparatide, or romosozumab. MACE outcomes included myocardial infarction (MI), stroke, atrial fibrillation (A-fib), and cardiac failure (CF), defined using Medical Dictionary for Regulatory Activities Preferred Terms. Disproportionality was assessed using reporting odds ratios (RORs), with signals defined by a lower 95% confidence interval >1. All analyses were descriptive and hypothesis-generating. FAERS contained more than 30 million adverse event reports during the study period. Romosozumab demonstrated the highest ROR for MI (2.38) and stroke (3.72), and also showed elevated signals for A-fib and CF (ROR 3.76). Zoledronic acid showed notable associations with stroke (ROR 2.42) and A-fib (ROR 3.22). Denosumab and abaloparatide were associated with the lowest RORs across all cardiovascular outcomes. Alendronate and risedronate demonstrated intermediate disproportionality signals, particularly for A-fib and CF. Romosozumab and zoledronic acid demonstrated prominent cardiovascular disproportionality signals in FAERS, whereas denosumab, abaloparatide, and teriparatide showed more favorable reporting profiles. These findings should not discourage osteoporosis treatment but underscore the importance of individualised cardiovascular risk assessment and the need for further prospective evaluation to inform safe therapy selection.

PMID 42756536
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PubMedCalcified tissue international2026-09-18

Anti-osteoporotic Pharmacotherapy and Muscle Outcomes in Osteosarcopenia: a Source-Verified Translational Evidence Map.

Lim Dong-Ju DJ, Kang Min Kue MK

Anti-osteoporotic drugs are increasingly discussed as candidate dual bone-muscle therapies in osteosarcopenia, yet clinical claims often conflate biological plausibility, observational signals, and randomized efficacy. We conducted a source-verified scoping evidence map and translational review, updated through 25 July 2026 using PubMed/MEDLINE, Europe PMC, and citation tracking. Evidence was classified as primary randomized evidence, secondary randomized analysis, observational human evidence, mechanistic/preclinical rationale, or review-level context; quantitative pooling was avoided because no drug-outcome pair had a sufficiently homogeneous randomized evidence base. Denosumab has the most coherent translational rationale through RANKL/RANK/NF-kB signaling, but randomized long-term-care data were neutral for muscle mass, strength, and performance despite bone mineral density improvement. Long-term-care context may reduce anabolic reserve, but a drug-by-exercise interaction remains unproven. Early pamidronate data in severe pediatric burns support prevention of resorption-linked muscle catabolism rather than reversal of established age-related sarcopenia. Bisphosphonates and teriparatide have preclinical or secondary signals; romosozumab and abaloparatide lack direct clinical muscle-efficacy evidence. Nandrolone is retained only as a historical positive control. Future trials should distinguish prevention from reversal and use factorial or rigorously standardized exercise designs with prespecified strength, muscle-mass, physical-performance, and pathway endpoints.

PMID 42758353
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PubMedJCEM case reports2026-09-17

Medication-related osteonecrosis of the external auditory canal and treatment with teriparatide.

Xia Daheng D, Ting Matthew J M MJM, Atlas Marcus D MD, Boeddinghaus Rudolf R et al.

Medication-related osteonecrosis of the external auditory canal (MROEAC) is a rare complication of antiresorptive therapy, and guidance for diagnosis and management remains limited. We describe 2 patients with prolonged antiresorptive exposure who developed MROEAC and were treated with teriparatide. An 81-year-old woman developed bilateral external auditory canal erosions after 10 years of denosumab therapy. An 8-week course of teriparatide was associated with clinical improvement and a transient rise in bone formation markers, but computed tomography findings remained unchanged. Denosumab withdrawal led to delayed rebound bone resorption, prompting denosumab reintroduction. A 67-year-old woman developed left-sided MROEAC after 15 years of alendronate followed by a short course of denosumab. Four months of teriparatide was associated with symptomatic and biochemical improvement, but radiologic abnormalities persisted, and definitive surgery was required. These cases highlight the difficulty of differentiating MROEAC from more common otologic disorders, the discordance between clinical, biochemical, and radiologic response, the importance of multidisciplinary management, and therapeutic challenges created by denosumab discontinuation. Teriparatide was well tolerated and was associated with increased bone turnover markers, but radiologic resolution was incomplete. Surgical management may still be necessary.

PMID 42751062
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PubMedStomatologija2026-09-14

Advances in the prevention and management of bisphosphonate-related osteonecrosis of the jaw: A literature review.

Ilekis Benas B, Varoneckaitė Salma S, Žilinskas Juozas J

Bisphosphonate-related osteonecrosis of the jaw (BRONJ) emerges as a serious side effect of bisphosphonate treatment worldwide, significantly impairing patients' oral health and overall quality of life. Ongoing research shows emerging treatment modalities such as a combination of pentoxifylline and tocopherol, teriparatide, and platelet concentrates that enhances the prospects of BRONJ treatment. However, the need for more accurate and predictable treatment options still remains. The aim of this review is to summarize and ascertain the current prevention and treatment strategies of BRONJ. A narrative literature review was conducted using the PubMed, Wiley Online Library, ScienceDirect, and Springer databases using the Medical Subject Headings (MeSH) terms including "Osteonecrosis of the Jaw," "Disphosphonates," "Teriparatide," "Platelet-Rich Plasma," and "Pentoxifylline". Inclusion criteria comprised clinical studies involving human subjects that evaluated prevention or treatment strategies for bisphosphonate-related osteonecrosis of the jaw. Randomized controlled trials, prospective and retrospective cohort studies, and clinical comparative studies published in English between 2015 and 2025. The literature search was conducted in January 2025. Emerging prevention and treatment strategies, including teriparatide and the combination of pentoxifylline and tocopherol, show potential in improving clinical outcomes and reducing disease progression. Although emerging treatment methods show promising results, BRONJ continues to pose significant clinical challenges.

PMID 42734616
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PubMedArchives of osteoporosis2026-09-03

Teriparatide treatment of osteoporosis in solid organ transplant recipients-a single-center experience.

Diker Cohen Talia T, Shraga-Slutzky Ilana I, Kaminer Keren K, Gorshtein Alexander A et al.

Solid organ transplant recipients face high fracture risk with limited evidence guiding anabolic therapy. In this real-world cohort, teriparatide was associated with significant improvements in bone mineral density and acceptable safety without adverse graft effects. These findings support selective anabolic treatment in high-risk transplant recipients and highlight the need for prospective studies. Solid organ transplant (SOT) recipients are at high risk for osteoporosis and fragility fractures due to pre-existing organ dysfunction and long-term immunosuppressive therapy, particularly glucocorticoids. However, evidence supporting the use of anabolic osteoporosis therapy in this population remains limited. We conducted a retrospective cohort study at a large transplant center including adult kidney, lung, and liver transplant recipients selected for teriparatide treatment based on clinical indications for severe post-transplant osteoporosis for at least 3 months. Bone mineral density (BMD), incident fractures, biochemical parameters, renal function, and adverse events were evaluated during treatment and follow-up. Thirty-nine SOT recipients (33% men; mean age 61.3 ± 11.6 years) were included, comprising kidney (n = 10), lung (n = 20), and liver (n = 9) transplant recipients. Prior fragility fractures were present in 90% of patients, and 79% had multiple fractures. Median teriparatide treatment duration was 22.3 months. Significant increases in BMD were observed at the lumbar spine (+11 ± 15%, p = 0.01), femoral neck (+8 ± 14%, p = 0.05), and total hip (+11 ± 16%, p = 0.05). Six patients sustained fractures after teriparatide initiation; only two occurred during active therapy, whereas four occurred after treatment discontinuation. Hypercalcemia occurred in one patient and led to treatment cessation. The estimated glomerular filtration rate declined modestly during the first 6 months and stabilized thereafter; a broadly similar pattern was observed in contemporaneous matched transplant controls. No episodes of graft rejection were observed. In this real-world cohort of SOT recipients with severe osteoporosis, teriparatide therapy was associated with significant improvements in BMD, acceptable safety, and no apparent excess risk to graft function. These findings support the selective use of anabolic therapy in high-risk transplant recipients and highlight the need for prospective studies to define optimal treatment strategies.

PMID 42684545
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