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DRUG:

Odomzo (sonidegib)

i
Other names: LDE225, LDE 225, NVP LDE225, NVP-LDE225, LDE-225, NVPLDE225
Company:
Novartis, Sun Pharma
Drug class:
Hedgehog cell-signalling pathway inhibitor
17d
SONIB: A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma (clinicaltrials.gov)
P2, N=20, Recruiting, Melanoma Institute Australia | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
Trial completion date • Trial primary completion date
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Odomzo (sonidegib) • Zyclara (imiquimod)
1m
A case of basal cell nevus syndrome with a SUFU mutation. (PubMed, Dermatol Online J)
Rarely, this condition is related to a suppressor of fused gene mutation, which occurs downstream from Smoothened, and is unresponsive to Smoothened inhibitors including vismodegib and sonidegib. Genetic testing was negative for patched 1 and patched 2 mutations but positive for a heterozygous suppressor of fused mutation. Patients with basal cell nevus syndrome should be treated with surgical excision, counseled on sun protection, screened and monitored for complications, and treated with vismodegib (if associated with patched 1 mutation) or itraconazole (if associated with suppressor of fused mutation).
Journal
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PTCH1 (Patched 1) • SUFU (SUFU Negative Regulator Of Hedgehog Signaling)
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Erivedge (vismodegib) • Odomzo (sonidegib) • itraconazole
1m
PersoMed-I: Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma (clinicaltrials.gov)
P2, N=20, Terminated, European Organisation for Research and Treatment of Cancer - EORTC | Trial completion date: Dec 2025 --> Sep 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Jun 2025; Poor accrual
Trial completion date • Trial termination • Trial primary completion date
|
TP53 (Tumor protein P53) • BRCA2 (Breast cancer 2, early onset) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
TP53 wild-type
|
cisplatin • vincristine • lomustine • Odomzo (sonidegib)
2ms
Sonidegib in Adult Patients With Locally Advanced Basal Cell Carcinoma (laBCC) in China (clinicaltrials.gov)
P4, N=160, Completed, Jemincare | Active, not recruiting --> Completed
Trial completion
|
Odomzo (sonidegib)
4ms
PersoMed-I: Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma (clinicaltrials.gov)
P2, N=20, Active, not recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Apr 2025 --> Dec 2025
Trial completion date • Trial primary completion date
|
TP53 (Tumor protein P53) • BRCA2 (Breast cancer 2, early onset) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
TP53 wild-type
|
cisplatin • vincristine • lomustine • Odomzo (sonidegib)
5ms
New trial
|
Odomzo (sonidegib)
5ms
NISSO: Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma (clinicaltrials.gov)
P=N/A, N=323, Completed, Sun Pharmaceutical Industries Limited | Active, not recruiting --> Completed | Trial completion date: Sep 2025 --> Mar 2025
Trial completion • Trial completion date
|
Odomzo (sonidegib)
6ms
Trial suspension
|
sorafenib • irinotecan • Odomzo (sonidegib)
7ms
Hyaluronan-decorated-phloroglucinol-loaded mesoporous silica downregulates GLI1 and SMO genes of hedgehog signaling pathway in gastrointestinal cancer stem-like cells. (PubMed, Int J Biol Macromol)
Furthermore, the expression analysis utilizing inhibitors such as GANT-61 (GLI1 inhibitor) and Sonidegib (SMO inhibitor) have demonstrated that the MSN-PG-HA has shown a significant level of inhibition as that of GANT-61, indicating a similarity in their mechanism of action in inhibiting the cancer cell proliferation. Thus, our findings conclude that MSN-PG-HA could serve as a potential drug for targeting GI cancer stem cells.
Journal
|
SMO (Smoothened Frizzled Class Receptor) • GLI1 (GLI Family Zinc Finger 1)
|
Odomzo (sonidegib)
7ms
UF-GI-015: AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma (clinicaltrials.gov)
P2, N=12, Recruiting, University of Florida | Phase classification: P1 --> P2
Phase classification
|
sorafenib • irinotecan • Odomzo (sonidegib)
8ms
Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study (clinicaltrials.gov)
P=N/A, N=80, Recruiting, Maastricht University Medical Center | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Jun 2026
Trial completion date • Trial primary completion date
|
Erivedge (vismodegib) • Odomzo (sonidegib)
8ms
Identification of RCC2 as a Risk Gene Associated With Basal Cell Carcinoma and Experimental Validation. (PubMed, Exp Dermatol)
While the sonic hedgehog (SHH) signalling pathway and mutations in PTCH1/2 and SMO are well-established drivers of BCC pathogenesis, novel genetic factors may complement existing therapeutic targets such as vismodegib and sonidegib. We identified a risk gene RCC2 associated with BCC by MR-based bioinformatics analysis and demonstrated that inhibition of RCC2 inhibited the proliferation of A431 in vitro. These findings provide new strategies for targeted therapy of BCC.
Journal
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PTCH1 (Patched 1) • SMO (Smoothened Frizzled Class Receptor)
|
Erivedge (vismodegib) • Odomzo (sonidegib)