Stelis Biopharma · PTH1R
teriparatide is a therapeutic agent developed by Stelis Biopharma. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.
| Brand Names | SBL001, Kauliv, SBL 001 |
| Company | Stelis Biopharma |
| Molecular Target | PTH1R |
| Route | Injectable (Others), Subcutaneous Injection |
| Status | Approved |
teriparatide acts on 1 molecular target:
| PTH1R | parathyroid hormone 1 receptor (PTHR, EKNS) |
teriparatide is developed for 1 unique indication across 1 therapeutic area.
| Therapeutic Area | Condition | Phase |
|---|---|---|
| Musculoskeletal and connective tissue disorders | Osteoporosis | ✓ Approved |
Han Xiaotong X, Yang Maowei M
Tskhakaia Irakli I, Danila Maria I MI
Osteoporosis is a chronic skeletal disorder in which reduced bone strength confers sustained fracture risk, often necessitating long-term pharmacotherapy with a multi-phase approach rather than a single "one and done" drug choice. Contemporary guidelines increasingly advocate a treat-to-target (TTT), goal-directed approach: clinicians define an explicit target, most often a total hip T-score threshold that corresponds to a lower fracture risk than baseline; select initial therapy according to baseline risk; and reassess and adjust treatment intensity until that target is achieved and maintained. Within this framework, sequential strategies are central. Anabolic-first sequences (e.g., abaloparatide or teriparatide followed by alendronate, or romosozumab followed by alendronate or denosumab) consistently produce larger and more durable gains in bone mineral density and fracture risk reduction in very-high-risk patients than antiresorptive monotherapy. Transitions from long-term bisphosphonates to teriparatide are complicated by transient increased remodeling and modest hip BMD responses, whereas switching to romosozumab yields more robust bone mineral density (BMD) gains at the hip. Notably, denosumab discontinuation demands structured bisphosphonate "exit" therapy to avoid rebound bone loss and multiple vertebral fractures. Across all pathways, rare but serious adverse events (e.g., atypical femoral fractures, medication-related osteonecrosis of the jaw, cardiovascular events), patient adherence and persistence, and insurance coverage constraints strongly shape the feasibility and desirability of specific regimens. This narrative review synthesizes mechanistic and clinical evidence underlying TTT osteoporosis care, summarizes the evidence base for sequential osteoporosis pharmacotherapy, and proposes practical strategies to help clinicians choose, transition, and discontinue therapies while preserving skeletal gains and minimizing harm over decades of longitudinal osteoporosis care.
Wang Yan Y, Wang Xiaoyan X, Yu Guihong G, Zhang Libao L et al.
Postmenopausal osteoporosis increases the risk of fractures, particularly in the lumbar spine, femoral neck, and total hip. Pharmacological interventions include anabolic agents (abaloparatide [ABA], teriparatide [TER]), antiresorptive agents (oral/intravenous bisphosphonates [OBP/IBP], denosumab [DEN]), and conventional therapy or placebo (PLA/CTRL). Evidence on their comparative efficacy and safety in postmenopausal women is limited. We conducted a Bayesian network meta-analysis of randomized controlled trials (RCTs) to evaluate the relative efficacy and safety of ABA, TER, OBP, IBP, DEN, and PLA/CTRL in postmenopausal women with osteoporosis. Primary outcomes included changes in lumbar spine, femoral neck, and total hip bone mineral density (BMD). Safety outcomes included all adverse events (AEs) and serious adverse events (SAEs). Data were synthesized using SUCRA rankings and network consistency was assessed via node-splitting and deviance information criteria (DIC). Twenty-three RCTs comprising 80-7, 808 postmenopausal women were included. ABA demonstrated the greatest improvement in lumbar spine and femoral neck BMD, followed by TER, while ABA showed the highest effect on total hip BMD. IBP and DEN provided moderate benefits, superior to PLA/CTRL. TER and OBP had the lowest risk for AEs, and ABA and PLA/CTRL showed the lowest risk for SAEs. Overall, anabolic agents significantly improved BMD at the spine and femoral neck, whereas antiresorptive agents were more effective for hip BMD. ABA and TER are most effective for improving spinal and femoral neck BMD in postmenopausal women, whereas ABA is superior for total hip BMD. Safety profiles were favorable for TER, OBP, and ABA. These findings provide evidence to guide individualized treatment selection based on fracture risk and high-risk skeletal sites in postmenopausal women.
Huang Shuyue S, Song Fuying F
In this retrospective case series, the clinical data of four pediatric patients with primary hypoparathyroidism (PHPT) treated with teriparatide at the Endocrinology Department of Capital Center for Children's Health, Capital Medical University, from May 2018 to May 2025, were analyzed. All patients were male and from four unrelated families. The ages at onset were 8 months, 12 years, 3 days, and 8 years plus 9 months, respectively, with time from onset to diagnosis ranging from several days to 1 year. The primary clinical manifestations of PHPT included seizures, tetany, and limb numbness. Seizures were observed in the two younger patients, whereas tetany or limb numbness were noted in the two older patients. Physical examination revealed positive Trousseau's sign or facial nerve signs. Laboratory test results showed hypocalcium, hyperphosphatemia, and decreased parathyroid hormone (PTH). Imaging revealed basal ganglia calcification in one patient and multiple small renal calculi in another. A heterozygous pathogenic variant in the CASR gene was identified by whole-exome sequencing in three patients, confirming a diagnosis of autosomal dominant hypocalcemia type 1 (ADH-1). All four patients had poor responses to conventional therapy (calcium supplements + vitamin D or its derivatives) and were subsequently treated with teriparatide (20 μg/dose, subcutaneously, 1-2 doses daily), with dose frequency adjusted based on serum calcium levels. Following 1 to 6 months of treatment, all patients achieved favorable outcomes, including normalization of serum calcium levels and resolution of clinical symptoms. No known teriparatide-related side effects were observed during treatment. Upon treatment discontinuation, patients smoothly transitioned to conventional therapy. Serum calcium levels were maintained at the lower limit of normal. Three patients experienced resolved clinical symptoms, while one patient experienced occasional tetany and numbness when the medicine was taken irregularly. Teriparatide (rhPTH1-34) effectively corrected hypocalcemia and alleviated clinical symptoms in pediatric PHPT, with a favorable safety profile. Therefore, teriparatide can be considered for children with refractory PHPT who do not respond adequately to conventional therapies.
Liu Jiahui J, Zhu Xi X, Liu Zhenguo Z, Li Ruiyu R
The incidence of atypical femoral fractures in breast cancer patients is theoretically expected to be significantly higher than in those with primary osteoporosis. This is due to the prolonged and higher dosages of bisphosphonates used for post-operative bone protection and secondary osteoporosis. However, there is a notable lack of literature addressing this issue. Diagnosing and managing atypical femoral fractures in breast cancer patients presents unique challenges that differ substantially from those encountered in osteoporosis patients. We present a 58-year-old postmenopausal woman with a history of breast cancer who reported bilateral mid-thigh pain. From June 2015 to January 2017, she received zoledronic acid (4 mg) intravenously every 3 months, totaling seven doses. From 2017 to 2021, her regimen changed to a 4 mg infusion every 6 months, resulting in ten doses during this period. Overall, she underwent 17 zoledronic acid infusions over approximately 5.5 years. After minor trauma, she suffered sequential bilateral femoral shaft fractures. Bone metastases were initially suspected but ruled out through histopathological examination of both fracture sites, which showed no malignancy. Following her last infusion in June 2024, a multidisciplinary team (MDT) discussion was held. Considering her prolonged bisphosphonate exposure, the fracture sites, and imaging consistent with the 2013 American Society for Bone and Mineral Research (ASBMR) criteria, she was diagnosed with bisphosphonate-related atypical bilateral femoral fractures. Zoledronic acid was discontinued, and teriparatide treatment began, leading to significant pain relief, improved mobility, and radiological evidence of fracture healing after 9 months. However, due to mildly elevated tumor markers (CA19-9 and neuron-specific enolase [NSE]), teriparatide was switched to denosumab, which led to a prompt recurrence of bilateral thigh pain. This case underscores the critical importance of early and differential diagnosis of atypical femoral fractures in this patient population. The findings suggest that teriparatide can be effective in promoting atypical femoral fracture healing; however, its use in patients with a history of cancer remains controversial and requires individualized risk-benefit assessment under multidisciplinary guidance. Furthermore, switching to denosumab during active fracture healing may lead to symptomatic recurrence. This approach might also be relevant for patients with primary osteoporosis. Multidisciplinary management and long-term monitoring are crucial for managing such complex cases.
Günay Aylin A, Kaygusuz Sare Betül SB, Akgülle Ahmet Hamdi AH, Bavaneh Motasim Khalid MK et al.
Osteogenesis imperfecta (OI) type VIII is an autosomal recessive skeletal dysplasia caused by P3H1 variants, resulting in defective collagen post-translational modification and increased bone fragility. Teriparatide (TPTD), a recombinant parathyroid hormone analogue, stimulates osteoblast activity and bone formation and is approved for the treatment of osteoporosis in adults. A 16-year-old male with genetically confirmed OI type VIII presented with delayed union with characterized by the absence of radiographic evidence of healing six months after femoral osteotomy and intramedullary rodding surgery. His prior management included intermittent bisphosphonate therapy which had improved bone mineral density. He had no recent history of fractures. Off-label therapy with TPTD (20 µg/day subcutaneously) was initiated and continued for six months. Although systemic markers of bone formation showed no remarkable changes, except osteocalcin, during therapy, serial radiographs confirmed successful bone union. The treatment was well tolerated, with no reported side effects; however, mild hypercalcemia with hypercalciuria, which persisted after discontinuation of TPTD therapy, was detected. Bisphosphonate therapy was resumed upon completion of TPTD treatment. This case represents the first documented use of TPTD to promote osteotomy healing in an adolescent with OI. The favourable clinical and radiologic outcome suggests a potential role for anabolic therapy in managing complex bone healing challenges in paediatric OI. Further research is warranted to evaluate safety and efficacy in this population.
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