Wnt Signaling Inhibitors 

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  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Trial completion date, Trial primary completion date:  Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients (clinicaltrials.gov) -  Jun 17, 2025   
    P4,  N=70, Recruiting, 
    These results highlight the promise of targeted TME reprogramming as a strategy to overcome TNBC's recalcitrance to immunotherapy. Trial completion date: Dec 2027 --> Dec 2029 | Trial primary completion date: Oct 2027 --> Apr 2029
  • ||||||||||  Erivedge (vismodegib) / Roche
    Review, Journal:  Prevalence of genetic alterations in basal cell carcinoma patients resistant to Hedgehog pathway inhibitors: a systematic review. (Pubmed Central) -  Jun 16, 2025   
    We included three prospective cohort studies encompassing 27 samples, all of which were resistant to vismodegib treatment...This systematic review highlights the prevalence of genetic alterations in the Hh pathway in BCC and offers insights into the mechanisms involved in treatment resistance. Understanding the high resistance rates of these genes may facilitate the development of more effective targeted therapies for BCC.
  • ||||||||||  methotrexate / Generic mfg., Erivedge (vismodegib) / Roche
    Review, Journal, PD(L)-1 Biomarker, IO biomarker:  Breaking barriers: exploring blood-brain barrier crossing mechanisms with nanomedicine for effective glioma treatment. (Pubmed Central) -  Jun 16, 2025   
    Additionally, fucoidan-encapsulated Vismodegib nanoparticles effectively crossed the BBB and exhibited minimal toxicity in healthy brain tissue...Despite the success in preclinical studies, challenges remain regarding nanoparticle biocompatibility, off-target effects, and regulatory approval. Nevertheless, these findings support the potential of multifunctional nanomedicines for glioma therapy by enabling BBB penetration, immune modulation, and targeted drug delivery, which can be further improved.
  • ||||||||||  Odomzo (sonidegib) / Sun Pharma
    Trial suspension:  UF-GI-015: AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma (clinicaltrials.gov) -  Jun 16, 2025   
    P2,  N=12, Suspended, 
    Nevertheless, these findings support the potential of multifunctional nanomedicines for glioma therapy by enabling BBB penetration, immune modulation, and targeted drug delivery, which can be further improved. Recruiting --> Suspended
  • ||||||||||  Odomzo (sonidegib) / Sun Pharma, Erivedge (vismodegib) / Roche
    Journal:  Eight-Year Experience of Hedgehog Pathway Inhibitors at Three Tertiary Referral Centres in the Australian State of Victoria. (Pubmed Central) -  Jun 10, 2025   
    Secondary acquired drug resistance occurred in 77% (10/13) of locally advanced and metastatic BCC patients after a median duration of 13?months. Further work is needed to optimise the neoadjuvant use of Hedgehog inhibitors with radiotherapy or surgery given poor long-term Hedgehog inhibitor tolerability and to develop strategies to counteract the issue of acquired resistance.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Journal, HEOR:  Comparative effectiveness of romosozumab versus teriparatide for fracture prevention: A new-user, active comparator design. (Pubmed Central) -  Jun 9, 2025   
    Both NMA and MAIC methods generated consistent results, demonstrating a benefit of ivosidenib?+?azacitidine versus other therapies for the treatment of newly diagnosed IDH1m AML. In this nationwide Japanese cohort, romosozumab use was associated with a lower incidence of major osteoporotic fractures compared to teriparatide over both 1- and 2-year follow-up periods among high-risk patients with osteoporosis.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Journal:  Romosozumab increases bone mineral density in Japanese older adults with osteoporosis. (Pubmed Central) -  Jun 9, 2025   
    In this nationwide Japanese cohort, romosozumab use was associated with a lower incidence of major osteoporotic fractures compared to teriparatide over both 1- and 2-year follow-up periods among high-risk patients with osteoporosis. Romosozumab improved BMD at the lumbar spine, total hip, and femoral neck in older adults with osteoporosis.
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Journal:  Fragility of Evidence for the Efficacy of Anti-fracture Medications. (Pubmed Central) -  Jun 9, 2025   
    The existing RCT evidence of anti-fracture efficacy is highly fragile. The FI, its comparison with loss to follow-up and FQ should be incorporated into clinical guideline development and doctor-patient risk communication.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Journal:  Development of a novel macroscopic regulation and microscopic intervention mode nanosystem for osteoporosis treatment. (Pubmed Central) -  Jun 6, 2025   
    Upon degradation, romosozumab is controllably released to inhibit sclerostin (SOST), while laser-triggered activation of endogenous nitric oxide (NO) stores suppresses Dickkopf-1 (DKK1)...The system's efficacy has been validated in both in vitro and in vivo osteoporosis models. Our work presents a promising therapeutic platform that combines macro-regulation and micro-intervention to address the multifactorial pathology of osteoporosis and enable precise, efficient bone regeneration.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Romosozumab Increases Spine and Hip Bone Mineral Density in Women With Anorexia Nervosa (ENDOExpo: Poster Area) -  Jun 5, 2025 - Abstract #ENDO2025ENDO_3391;    
    Romosozumab was well tolerated. In conclusion, in this pilot, randomized, placebo-controlled study, 12 months of therapy with romosozumab markedly increased spine and hip BMD in women with anorexia nervosa, increasing BMD Z-score to >-1 in a significant number of women.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Bone Gains and Heart Strains: Romosozumab and Cardiovascular Safety (ENDOExpo: Poster Area) -  Jun 5, 2025 - Abstract #ENDO2025ENDO_3390;    
    These findings suggest there is no heightened risk for major adverse cardiovascular events in patients with osteoporosis treated with romosozumab compared to anabolic agents (teriparatide or abaloparatide). Further observational data is required to concur such findings, which may lead to a discontinuation of the black-box warning.
  • ||||||||||  cyclopamine / University of Macau
    Journal:  Hedgehog signaling during gut formation in the freshwater leech, Helobdella austinensis. (Pubmed Central) -  Jun 3, 2025   
    This study confirms that the hedgehog signaling pathway is associated with gut development in the freshwater leech, H. austinensis. The expression patterns of hedgehog pathway genes and their interaction with NK genes suggest a role of hedgehog signaling in regulating gut development rather than segmentation in the freshwater leeches.
  • ||||||||||  Odomzo (sonidegib) / Sun Pharma, Libtayo (cemiplimab-rwlc) / Regeneron, Erivedge (vismodegib) / Roche
    Review, Journal:  Current treatment options for locally advanced and metastatic basal cell carcinoma. A narrative review. (Pubmed Central) -  Jun 1, 2025   
    In between this spectrum, oral hedgehog inhibitors including vismodegib and sonidegib, electrochemotherapy, different types of radiotherapy, and surgery can be considered...The management of laBCC and mBCC patients is determined by a multidisciplinary dermato-oncology board, including dermatologists, medical oncologists, radiotherapists, pathologists, and surgeons, as well as the patient's GP. Today, experts recommend keeping as long as possible laBCC and mBCC patients under sequential courses of HHIs, if surgery and/or radiotherapy are not amenable.
  • ||||||||||  taladegib (ENV 101) / Endeavor BioMed
    Trial completion date, Trial primary completion date:  A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) (clinicaltrials.gov) -  May 30, 2025   
    P2,  N=200, Recruiting, 
    Suspended --> Recruiting Trial completion date: Jun 2026 --> Oct 2026 | Trial primary completion date: Jun 2026 --> Oct 2026
  • ||||||||||  Halaven (eribulin mesylate) / Eisai
    Journal, Adverse events, Monotherapy:  The Effectiveness and Adverse Events of Eribulin Monotherapy in Indonesian Metastatic Breast Cancer (MBC) Patients. (Pubmed Central) -  May 29, 2025   
    This study suggests that eribulin monotherapy is associated with disease control and survival benefits in Indonesian MBC patients while maintaining a manageable safety profile. However, further prospective studies are needed to confirm its long-term efficacy, impact beyond 6 cycles, and comparative effectiveness relative to other chemotherapy regimens.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    ROMOSOZUMAB IN PATIENTS WITH OSTEOPOROSIS: SAFETY AND EFFICACY ANALYSIS IN CLINICAL PRACTICE () -  May 28, 2025 - Abstract #EULAR2025EULAR_3563;    
    An increase in bone formation markers and a reduction in bone resorption markers were observed in blood tests, along with an improvement in bone mineral density as measured by densitometry. The most commonly used treatment following romosozumab was denosumab, followed by bisphosphonates.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Review, Journal:  Role of Sclerostin in Cardiovascular System. (Pubmed Central) -  May 28, 2025   
    Humanized anti-sclerostin antibody, romosozumab, was approved for treatment of postmenopausal osteoporosis by the US Food and Drug Administration (FDA), but with a black-box warning on cardiovascular risk...Sclerostin in human aortic smooth muscle cells participated in the reduction in calcium deposition. The role of sclerostin in cardiovascular system deserves further investigation.