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teriparatide (SBL001 / Kauliv / SBL 001)

✓ Approved

Stelis Biopharma · PTH1R

什么是 teriparatide？

teriparatide 是一种治疗药物，由Stelis Biopharma研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Subcutaneous Injection。

药物档案

商品名SBL001, Kauliv, SBL 001
公司Stelis Biopharma
分子靶点PTH1R
给药途径Injectable (Others), Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, Stelis Biopharma

作用机制

分子靶点

teriparatide 作用于 1 个分子靶点：

PTH1Rparathyroid hormone 1 receptor (PTHR, EKNS)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

teriparatide 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Musculoskeletal and connective tissue disordersOsteoporosis✓ Approved

相关研究文献

PubMedInternational journal of biological macromolecules2026-07-31

Intein-mediated high-yield expression of recombinant teriparatide.

Gu Ruocheng R, Di Rouyu R, Yang Chunle C, Lin Fei F et al.

Teriparatide, a recombinant fragment of parathyroid hormone (rPTH), is employed in the treatment of osteoporosis. However, its biosynthesis is hampered by several challenges, including host-mediated degradation, low expression levels, and the high costs associated with affinity tag removal. In this study, a gp41-1 mutant with demonstrated high traceless cleavage activity was fused to teriparatide to address these issues and develop an intein-mediated high-yield expression system. D107Ggp41-1 presented relatively low unexpected cleavage in vivo (30%-40%, over 50% for other inteins) and a great cleavage efficiency in vitro, reaching 90% completion within 4 h. An optimized fed-batch fermentation process, incorporating refined induction conditions and carbon source selection, was developed to enhance teriparatide production, resulting in a final yield of 1.3 g/L. Following secondary purification, the purity of recombinant teriparatide (rTeriparatide) exceeded 98%. This scalable fermentation process for high teriparatide production that utilizes gp41-1-mediated expression system, presenting a promising foundation for efficient industrial manufacturing.

PMID 42532234
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PubMedJournal of osteoporosis2026-07-31

Cardiovascular Outcomes Following Therapeutic Sclerostin Inhibition Compared With Alternative Anabolic Therapies: A Real-World Propensity Score-Matched Analysis.

Barnett Maxim John Levy MJL, Lam Justin J, Anastasopoulou Catherine C

Romosozumab is a dual antiresorptive/anabolic monoclonal antibody against sclerostin, approved for osteoporosis. Largely driven by the ARCH trial, unexpected concerns for cardiovascular safety arose, mandating a black-box warning. Despite numerous subsequent investigations, the true nature of this association is unelucidated. Real-world data were analyzed through TriNetX network, further clarifying this association. Over 1 year, we analyzed patients aged > 50 with osteoporosis, exposed to romosozumab (Cohort A) or teriparatide/abaloparatide (Cohort B), with propensity score matching. We did not exclude patients with outcomes of interest prior to the index event. We observed a significant association with lower hazard ratios among four- (HR 0.441, 95% CI 0.0.376-0.638, p < 0.0001) and three-point major adverse cardiovascular events (HR 0.624, 95% CI 0.567-0.688, p < 0.0001), with improved survival probabilities among Cohort A. Romosozumab participants continued to demonstrate a significantly lower hazard (and improved survival probabilities) of myocardial infarction, heart failure, and death, but no significant difference was observed with respect to cerebrovascular accidents. Subsequent E-value sensitivity analyses suggested moderate robustness to unmeasured confounding. Further subgroup analyses were performed over two and five years of follow-up, among patients aged 50-64 and > 65, along with male- and female-only cohorts. The true association between romosozumab and cardiovascular events remains unknown. Additional studies of a prospective nature are required to investigate this further. These findings do not demonstrate a clear increased cardiovascular risk signal in a real-world setting; however, they should be interpreted as associative rather than causal and are not sufficient to change current regulatory recommendations.

PMID 42535103
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PubMedBone research2026-07-31

DMP1-Cre expressing cells mediate the gain in bone mass and strength, but not the increase in bone remodeling, induced by ligands of the parathyroid hormone receptor.

Akel Nisreen N, Uppuganti Sasidhar S, Thostenson Jeff D JD, House Wyatt W et al.

Signaling downstream of the receptor of parathyroid hormone (PTH1R) exerts two major skeletal effects: increases bone remodeling and, when stimulated intermittently, induces bone anabolism. Osteocytes express the PTH1R and are critical for the action of teriparatide/parathyroid hormone 1-34 (PTH). However, it is unknown whether they also mediate the effects of abaloparatide (a 34 amino acid synthetic analog of human parathyroid hormone-related protein, ABL), and whether actions on osteocytes are required for the increase in remodeling and/or the bone gain induced by PTH/ABL in diabetes. We addressed these questions by treating with PTH or ABL control or diabetic (DM) mice lacking the PTH1R in DMP1-Cre expressing cells that targets all osteocytes (cKO). Both PTH and ABL increased bone mass and improved or corrected cortical and trabecular bone microarchitecture only in fl/fl littermates but not in cKO, control or DM mice. Further, PTH/ABL increased bone strength and microindentation resistance only in control or DM fl/fl mice. In contrast, PTH/ABL increased serum P1NP and bone formation on cancellous, periosteal and endocortical surfaces, in control or DM mice of both genotypes. Moreover, serum CTX and osteoclast surface were increased by PTH/ABL in fl/fl and cKO, control or DM mice. Thus, actions on DMP1-Cre expressing cells are required for bone gain, microarchitecture restoration, strength and resistance to fracture, exerted by PTH and ABL under physiological and DM conditions, but not for the increase in bone remodeling. These findings demonstrate the dissociation of bone gain from bone remodeling and reveal that actions on DMP1-Cre expressing cells drive the gain in bone mass and strength induced by PTH and ABL.

PMID 42532988
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PubMedJournal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons2026-07-29

Should Teriparatide Be Part of Our Clinical Armamentarium in the Management of Medication-Related Osteonecrosis of the Jaw? A Systematic Review and Meta-Analysis.

Sheridan Samuel S, Rafati Sahm S, Patel Nisarg N

Medication-related osteonecrosis of the jaw (MRONJ) is a severe and potentially debilitating drug reaction. Adjunctive treatments including pentoxifylline, tocopherol, and teriparatide (TPTD) have been studied, but TPTD's efficacy remains unclear. This systematic review and meta-analysis aims to consolidate and evaluate high-quality evidence on TPTD in managing MRONJ. An electronic search strategy was performed on 3 databases (Pubmed, Embase, and Cochrane CENTRAL). Search terms include ("Teriparatide" OR "TPTD" OR "Recombinant Parathyroid Hormone" OR "Recombinant PTH") AND ("Medication-Related Osteonecrosis of the Jaw" OR "MRONJ" OR "BRONJ"). No publication date range was utilized. Inclusion criteria include randomized controlled trials, case-control studies, and cohort studies. All systematic reviews, case reports, case series, animal studies, editorials, non-English publications, or studies relating to osteoradionecrosis were excluded. Each study was screened independently, followed by final study selection after discussion with all authors. Primary meta-analysis used Cox proportional hazards regression with pseudo-individual-subject data reconstructed from published Kaplan-Meier curves (Guyot method) and a Tierney events + P value derivation for one study without Kaplan-Meier data. A sensitivity analysis pooled odds ratios (ORs) at the 6-month clinical response endpoint. Primary outcomes include improvement in MRONJ clinical staging. Secondary outcomes include time to improvement, adverse effects, radiographic evaluation, and presence of serum markers. After review of 162 studies, 5 (3.1%) studies were included in the systematic review with 3 (1.9%) studies included in the meta-analysis (n = 101 subjects). A three-study Cox hazard ratio (HR) meta-analysis yielded a pooled HR of 5.35 (95% CI, 3.14 to 9.13, P < .0001, I2 = 0%) favoring TPTD. Subgroup analyses by dosing regimen showed directionally consistent effects (daily pooled HR = 12.52; 95% CI, 5.75 to 27.23; weekly pooled HR = 8.09; 95% CI, 3.59 to 18.26; both I2 = 0%), and an OR-based sensitivity analysis at the 6-month binary healing endpoint was directionally concordant (pooled OR = 14.26; 95% CI, 2.83 to 71.77). Adjunctive TPTD shows improvement of MRONJ staging and time to healing compared to conventional treatments alone, but the magnitude of the impact remains unclear. Additional evidence, including studies evaluating dosing regimens and subject segmentation by MRONJ staging, is warranted.

PMID 42521191
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PubMedCalcified tissue international2026-07-29

Strontium Treatment Potentiates Bone Anabolic Action of Intermittent PTH in Ovariectomized Rats.

Thouverey Cyril C, Badoud Isabelle I, Ammann Patrick P

To optimize osteoporosis therapy with the parathyroid hormone fragment teriparatide (PTH1-34), we sought to determine whether strontium (Sr) could potentiate the bone anabolic action of intermittent PTH1-34 in ovariectomized rats. Female rats were either Sham-operated or ovariectomized (Ovx) at 6 months of age. Eight weeks after surgery, Ovx rats received either vehicle solutions, 625 mg/kg/day Sr (5 days per week), 8 µg/kg/day PTH1-34 (5 days per week), or the combined treatments for 8 weeks. PTH1-34 reversed Ovx-induced deterioration of trabecular microarchitecture, apparent volumetric bone mineral density (vBMD), and strength, whereas Sr alone increased tissue-level vBMD without significantly affecting trabecular bone mass. Co-treatment with Sr and PTH1-34 further increased trabecular thickness (+ 8.9% vs. PTH1-34 alone), apparent and tissue-level vBMD (+ 9.6% and 6.7% vs. PTH1-34 alone), bone material properties (maximum force, + 18.2% vs. PTH1-34 alone; working energy, + 17% vs. PTH1-34 alone), and trabecular bone strength compared with PTH1-34 alone. In cortical bone, PTH1-34 increased bone volume, cortical thickness, and apparent vBMD, while co-treatment further enhanced cortical thickness (+ 7.2% vs. PTH1-34 alone) and apparent vBMD (+ 7% vs. PTH1-34 alone), maintained the Sr-induced increase in tissue-level vBMD, and significantly improved bone strength. In primary osteoblast cultures, Sr and PTH1-34, administered either alone or in combination, increased Rankl and decreased Opg expression, consistent with the elevated urinary levels of the bone resorption marker deoxypyridinoline in vivo. Sr or PTH1-34 alone stimulated Igf1 and Alpl expression, whereas co-stimulation further enhanced these osteogenic markers. In conclusion, combining Sr with PTH1-34 integrates the osteoanabolic effects of PTH1-34 on bone mass with the mineral-level effects of Sr on bone material properties, leading to synergistic stimulation of bone formation and superior improvements in bone quality and strength.

PMID 42521883
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PubMedJournal of clinical medicine2026-07-28

Impact of Preoperative Teriparatide Use on Proximal Junctional Kyphosis Prevention in Osteopenic/Osteoporotic Patients Undergoing Adult Spinal Deformity Surgery: A Propensity Score-Matched Study.

Oh Jun-Seok JS, Park Jin-Sung JS, Kang Dong-Ho DH, Park Seungjae S et al.

Background/Objectives: Poor bone quality significantly increases the risk of mechanical complications after adult spinal deformity (ASD) surgery, including proximal junctional kyphosis (PJK) and proximal junctional failure (PJF). Although teriparatide enhances bone quality, its effectiveness in preventing junctional complications after extensive correction remains unclear. This study investigated whether preoperative teriparatide administration reduces the incidence of PJK and PJF in patients with compromised bone quality undergoing ASD surgery. Methods: This retrospective cohort study reviewed 292 patients (T-score < -1.0) who underwent ASD surgery between 2015 and 2023. Patients were divided into teriparatide (n = 59) and non-teriparatide (n = 233) groups. Propensity score matching (1:2 ratio) was performed using six covariates: age, preoperative pelvic incidence minus lumbar lordosis, preoperative T1 pelvic angle, upper instrumented vertebra (UIV) cementing, UIV screw angle, and fusion length, yielding 153 matched patients (52 teriparatide, 101 non-teriparatide). Results: After matching, all baseline characteristics were statistically similar, with no significant differences. The incidence of PJK and PJF did not differ significantly between the teriparatide and non-teriparatide groups (44.2% vs. 52.5%, p = 0.426; 9.6% vs. 9.9%, p = 1.000), nor did PJK subtype distribution (bony vs. soft-tissue). Multivariate analysis identified older age (odds ratio [OR] = 1.058), higher American Society of Anesthesiologists score (OR = 2.603, p = 0.002), UIV at the thoracolumbar junction (OR = 2.786), and greater postoperative thoracic kyphosis (OR = 1.044) as independent risk factors for PJK. Teriparatide use was not an independent predictor (OR = 0.872). Conclusions: Preoperative teriparatide did not significantly reduce the incidence of PJK or PJF after long-segment fusion for ASD. These findings suggest that improving bone quality alone is insufficient to prevent junctional complications, which are driven by complex biomechanical and patient-related factors inherent to extensive deformity correction.

PMID 42513596
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