Fumena (vorolanib) / Tyrogenex, Betta Pharma - LARVOL DELTA

Interim analysis of vorolanib combined with cadonilimab in previously untreated patients with advanced renal cell carcinoma. (ASCO-GU 2026) - P1/2 | "Vorolanib has demonstrated OS benefit and safety as monotherapy or combined with everolimus in later-line settings... The combination of vorolanib and cadonilimab represents a 1L treatment option for aRCC, demonstrating a high ORR and favorable tolerability. Further large-scale studies are warranted to validate OS, PFS, and long-term safety. PD-L1+ CTCs show potential as predictive biomarkers for treatment efficacy."

Clinical • IO biomarker • Metastases • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CTLA4

A Single-Arm, Single-Center Clinical Study of Vorolanib Combined with Toripalimab as First-Line Therapy for Metastatic Clear Cell Renal Cell Carcinoma (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Xi'an Jiaotong University; The First Affiliated Hospital of Xi'an Jiaotong University

New P4 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC (clinicaltrials.gov) - P2 | N=21 | Recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Clinical Study on the Efficacy and Safety of Sintilimab Combined with Vorolanib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma (ChiCTR) - P2 | N=48 | Not yet recruiting | Sponsor: Third Medical Center, Chinese PLA General Hospital; Chinese PLA General Hospital

IO biomarker • New P2 trial • Oncology • Solid Tumor • Urothelial Cancer • HER-2

Efficacy Evaluation of Vorolanib Combined with Sintilimab as First-Line Treatment for Advanced Non-Clear Cell Renal Cell Carcinoma (nccRCC): A ​​Multi-center, Single-Arm Study​ (ChiCTR) - P4 | N=35 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University​; The First Affiliated Hospital of Zhengzhou University?

New P4 trial • Genito-urinary Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Vorolanib + Atezolizumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=11 | Terminated | Sponsor: Washington University School of Medicine | Active, not recruiting ➔ Terminated; Insufficient Funding/Staff

Trial termination • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Comparison of Vorolanib Tablets Combined With Everolimus Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma Who Have Progressed After Treatment With Immunotherapy Monotherapy or in Combination With TKI (clinicaltrials.gov) - P3 | N=116 | Not yet recruiting | Sponsor: Peking University Cancer Hospital & Institute

Monotherapy • New P3 trial • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Role of alternative oral therapy for the management of wet age-related macular degeneration and proliferative diabetic retinopathy. (PubMed, World J Diabetes) - "While intravitreal anti-vascular endothelial growth factor injections are still the mainstay therapy, there are a few challenges, such as frequent administration, cost burden, and compliance barriers that prompt the need for exploration into systemic oral alternative drugs like fenofibrate, candesartan, and vorolanib. These oral therapies have the advantage of being non-invasive and systemically accessible with few logistical burdens. This review highlights current evidence supporting the use of oral therapies in PDR and wet ARMD management, along with practical limitations and future prospects."

Journal • Review • Age-related Macular Degeneration • Diabetes • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Metabolic Disorders • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Vorolanib Monotherapy or in Combination With Toripalimab as Adjuvant Therapy for Patients With Intermediate-high Risk of Recurrence in Renal Cell Carcinoma (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Dong Wen

Monotherapy • New P2 trial • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Treatment of Retinal/Choroidal Vascular Diseases by Sustained Delivery of VEGF Receptor Tyrosine Kinase Inhibitors. (PubMed, Am J Ophthalmol) - "Sustained delivery of VEGF receptor TKIs represents a promising therapeutic paradigm for retinal and choroidal vascular diseases, potentially reducing treatment burden while maintaining efficacy. Continued evaluation through larger, controlled clinical trials is essential to validate these early findings and define the role of these agents in clinical practice."

Clinical • Journal • Age-related Macular Degeneration • Cardiovascular • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A prospective, single-arm phase I/II clinical study of befotertinib in combination with vorolanib neoadjuvant in patients with stage II-IIIB EGFR-positive non-small cell lung cancer (ChiCTR) - P1/2 | N=39 | Not yet recruiting | Sponsor: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy and Safety of Vorolanib Monotherapy or in Combination with Toripalimab as Adjuvant Therapy for Intermediate-High Risk Early-Stage/Mid-Stage Renal Cancer Patients After Surgery: A Multicenter, Randomized, Double-Arm, Phase II Exploratory Study. (ChiCTR) - P2 | N=60 | Recruiting | Sponsor: Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Monotherapy • New P2 trial • Clear Cell Carcinoma • Clear Cell Renal Cell Carcinoma • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • PD-1

Efficacy and safety of Vorolanib in patients with inoperable progressive or symptomatic desmoid tumors:A prospective, single-arm, phase II study (ChiCTR) - P2 | N=18 | Recruiting | Sponsor: West China Hospital, Sichuan University; West China Hospital, Sichuan University

New P2 trial • Desmoid Tumors • Sarcoma

Beyond the injection: delivery systems reshaping retinal disease management. (PubMed, Expert Opin Pharmacother) - "Specific innovations discussed include the ranibizumab port delivery system, EYP-1901 (Duravyu, vorolanib implant), KSI-301 (tarcocimab tedromer), KSI-501, OTX-TKI (Axpaxli, axitinib implant), 4D-150, revakinagene taroretcel-lwey (Encelto, NT-501, encapsulated cell therapy), Xipere (triamcinolone acetonide injectable suspension), AU-011 (belzupacap sarotalocan targeted delivery), ABBV-RGX-314, elamipretide, and OCS-01 (high concentration dexamethasone)...Challenges include overcoming the blood-retinal barrier, surgical complications with implantable devices, and ensuring patient adherence. Advances in smart delivery systems, drug formulations, and predictive models, alongside interdisciplinary collaboration, will be crucial in achieving personalized, effective, and sustainable retinal therapies."

Journal • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders

Target and selectivity profiling of axitinib in cell-based and biochemical assays (ARVO 2025) - "Additionally, cell-based and radiometric kinase assays (33PanQinaseTM) were conducted at Reaction Biology, Germany, to evaluate half-maximal inhibitory concentration (IC50) of axitinib and vorolanib on VEGFR, PDGFR, FGFR, and TIE2 kinase activity with sunitinib as positive control. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Ophthalmology • FGFR • FLT1 • FLT4 • KDR • PDGFRA • PDGFRB

PAVIA phase 2 trial of EYP-1901 in nonproliferative diabetic retinopathy: 12-month results (ARVO 2025) - P2 | "EYP-1901 includes a bioerodible intravitreal insert for sustained-delivery of vorolanib, a pan-vascular endothelial growth factor receptor inhibitor, for ≥6 months. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

P2 data • Diabetic Macular Edema • Diabetic Retinopathy • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

12-month interim phase results from a good laboratory practice (GLP) pivotal repeat-dose toxicity study of EYP-1901 (vorolanib intravitreal insert) in Dutch-Belted rabbits (ARVO 2025) - "EYP-1901 has the potential to reduce the treatment burden in patients with wAMD if shown to be safe and effective.This study used Dutch-Belted rabbits to investigate the long-term safety of EYP-1901 with repeat dosing at a range of drug levels, to support use in phase 3 clinical trials. No adverse findings were observed, supportive of safety with repeat dosing.Clinical safety and efficacy of EYP-1901 will be assessed in the phase 3 trials LUGANO and LUCIA, enrolling patients globally with wAMD."

Preclinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Assessment of treatment burden in wet age-related macular degeneration treated with EYP-1901 (vorolanib intravitreal insert) versus aflibercept: DAVIO 2 trial results (ARVO 2025) - P2 | "All patients in DAVIO 2 had been treated for wet AMD before the trial.In DAVIO 2, 63% of EYP-1901-treated eyes did not need any additional aflibercept treatment to control their disease up to 6 months after receiving EYP-1901, with half of patients receiving their first supplemental treatment ~9-10 months after EYP-1901. Overall, this was an ~80% reduction in treatment burden versus how often these patients were treated before the trial, and 70% reduction versus patients receiving standard-of-care treatment during the trial."

Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

LUGANO and LUCIA trial design: Pivotal phase 3 studies of EYP-1901 vs aflibercept in wet age-related macular degeneration (ARVO 2025) - P2, P3 | "EYP-1901 provides sustained-release of the tyrosine kinase inhibitor, vorolanib, that acts as a selective pan-vascular endothelial growth factor receptor inhibitor...The phase 3 trials LUGANO and LUCIA will compare EYP-1901 given as an injection into the eye every 6 months versus the standard of care, aflibercept 2.0 mg (Eylea) given as an injection into the eye every 8 weeks...At each monthly visit, patients will be assessed to determine if supplemental treatment with aflibercept 2.0mg is needed to control their disease.The main objective of the study is to assess whether patients' vision after one year of EYP-1901 treatment is similar to vision of patients treated with aflibercept. Other objectives include determining if patients who received EYP-1901 required fewer injections and how safe the treatment is."

P3 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

VORSIN-RCC: Vorolanib plus sintilimab for advanced renal cell carcinoma after failure of prior immune checkpoint inhibitors-based combination therapy. (ASCO-GU 2025) - P2 | "A phase Ib/II single-arm trial achieved a high objective response rate (ORR) with lenvatinib plus pembrolizumab in patients post-ICI progression (Lee CH et al., Lancet Oncol 2021)...The failures of previous ICI re-challenges may be related to the limited efficacy of PD-L1 blockade (atezolizumab) in RCC and the reduced dosage of tivozanib, whose efficacy is closely related to its blood concentration...Clinical trial information: NCT06523049. Research Sponsor: Hao Zeng."

Checkpoint inhibition • Combination therapy • Metastases • Genito-urinary Cancer • Oncology • Solid Tumor

VERONA: Study of EYP-1901 in Patients With Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2 | N=27 | Completed | Sponsor: EyePoint Pharmaceuticals, Inc. | Recruiting ➔ Completed

Trial completion • Diabetic Macular Edema • Ophthalmology

Efficacy and Safety of Vorolanib Combined with Toripalimab as First-Line Treatment for Metastatic Clear Cell Renal Cell Carcinoma: A Multicenter, Open-Label Clinical Study (ChiCTR) - P2 | N=60 | Recruiting | Sponsor: Xi'an Jiaotong University Second Affiliated Hospital; Xi'an Jiaotong University Second Affiliated Hospital

New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

The study on efficacy and safety of Ensatinib combined with Vorolanib in the treatment of advanced non-small cell lung cancer with ALK positivity and high PD-L1 expression (ChiCTR) - P1/2 | N=49 | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • PD-L1

Vigor: Efficacy and Safety of Vorolanib Monotherapy As Third-line or Later Treatment for Advanced Non-small Cell Lung Cancer Patients: a Single-arm, Prospective, Open-label Phase II Clinical Study (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Li-kun Chen

Metastases • Monotherapy • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Vorolanib in the Second-line Treatment of Patients with Unresectable or Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - P=N/A | N=39 | Recruiting | Sponsor: Jinling Hospital, China

Metastases • New trial • Genito-urinary Cancer • Kidney Cancer • Nephrology • Oncology • Renal Cell Carcinoma • Renal Disease • Solid Tumor • Urethral Cancer • Urology