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

Drug-Drug Interaction Study of Vorolanib Tablets in Healthy Participants (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Betta Pharmaceuticals Co., Ltd.

New P1 trial

Pharmacokinetic Study of Vorolanib Tablets in Trial Participants With Hepatic Impairment (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Betta Pharmaceuticals Co., Ltd.

New P1 trial • Hepatology

Neoadjuvant befotertinib plus vorolanib in resectable stage II-IIIB EGFR-mutant NSCLC: a study protocol for the prospective, single-arm phase I/II trial. (PubMed, Transl Lung Cancer Res) - P1/2 | "The study may help define whether intensification of neoadjuvant targeted therapy can improve pathological regression in this molecularly selected population. Chinese Clinical Trial Registry (ChiCTR2500103324)."

Journal • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

First Discovery of the Dual-Functional Inhibitor Targeting VEGFR/PDGFR/CA II for the Treatment of Neovascular Glaucoma. (PubMed, J Med Chem) - "Compared with positive drugs Vorolanib and Acetazolamide, H24 exhibited better inhibitory activity against VEGFR2, PDGFRα/β and CA II enzymes. In acute and chronic glaucoma model, H24 significantly reduced the IOP of rabbits. Overall, these findings provided compelling evidence that H24 offers new perspectives in the treatment of NVG."

Journal • Glaucoma • Ophthalmology • KDR • PDGFRA

Combining in vivo and in vitro studies to elucidate the inhibitory effect of resveratrol on vorolanib metabolism. (PubMed, Front Pharmacol) - "Both in vitro and in vivo results consistently demonstrate that resveratrol profoundly inhibits the metabolism and elimination of vorolanib, driven by its interference with the CYP3A4 catalytic domain as corroborated by docking analysis. These findings highlight a potential risk of herb-drug interactions, suggesting that close clinical monitoring for adverse reactions is required when vorolanib and resveratrol are used in combination."

Journal • Preclinical • CYP3A4

DAVIO 2 Phase 2 Trial: Vision Outcomes with Bioerodible EYP-1901 (vorolanib intravitreal insert) Versus Aflibercept in Wet Age-Related Macular Degeneration (wAMD) (ARVO 2026) - P2, P3 | "Patients' vision in the treated eye stayed above a level considered important for daily activities, such as driving, for most days in the 6 months following treatment with a single EYP-1901 dose, similar to treatment with aflibercept every 8 weeks. EYP-1901 with dosing every 6 months is being studied in larger global phase 3 clinical studies LUGANO and LUCIA."

P2 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • IL6

DAVIO 2 phase 2 trial of bioerodible EYP-1901 (vorolanib intravitreal insert) for wet age-related macular degeneration: Results in subgroup that met LUGANO/LUCIA phase 3 inclusion criteria (ARVO 2026) - P2, P3 | "When data from DAVIO 2 was evaluated in the group of patients that were similar to those enrolled in the phase 3 studies, results were similar to the full trial population. Data from LUGANO are expected in mid-2026 with LUCIA soon after."

P2 data • P3 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • IL6 • JAK1

Development of EYP-1901, a bioerodible intravitreal (IVT) insert for sustained release of the tyrosine kinase inhibitor (TKI) vorolanib for retinal exudative disease (ARVO 2026) - P2, P3 | "EYP-1901 has been optimized to increase the amount of drug in each insert while maintaining insert integrity and providing similar drug release. EYP-1901 has completed phase 2 trials in wAMD and DME, and phase 3 trials have either started or will be starting soon."

Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • IL6 • JAK1

Vorolanib inhibition of IL-6 signaling: A novel multi-mechanism of action for EYP-1901 in retinal exudative diseases (ARVO 2026) - "Diseases such as wAMD and DME are multifactorial – involving the excessive formation of blood vessels in the eye in addition to inflammatory processes. Ongoing work shows that the drug vorolanib works in a unique way to address both of these aspects of retinal disease simultaneously."

Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • IL6 • IL6R • JAK1

VERONA phase 2 clinical trial of bioerodible EYP-1901 (vorolanib intravitreal insert) versus aflibercept for diabetic macular edema (DME): Visual, anatomic, and angiographic outcomes (ARVO 2026) - P2 | "EYP-1901 was well-tolerated. EYP-1901 high dose will be further evaluated for DME in phase 3 trials COMO and CAPRI."

Clinical • P2 data • Diabetic Macular Edema • Ophthalmology • IL6 • JAK1

COMO and CAPRI trial design: Pivotal phase 3 non-inferiority studies of EYP-1901 vs on-label aflibercept in diabetic macular edema (ARVO 2026) - P2 | "EYP-1901 (vorolanib intravitreal insert) provides sustained release of vorolanib, a tyrosine kinase inhibitor with a novel multi-mechanism of action (MoA) providing pan-VEGF receptor inhibition in addition to blocking pro-inflammatory IL-6 signaling. EYP-1901 will be re-dosed every 6 months and compared to standard-of-care aflibercept injections every 8 weeks. The trials will aim to demonstrate similar vision outcomes with EYP-1901, but with fewer injections."

Head-to-Head • P3 data • Diabetic Macular Edema • Ophthalmology • IL6

Prospective, multi-center, single-arm phase II clinical study of the efficacy and safety of vorolanib monotherapy as adjuvant treatment in intermediate-high risk resectable renal cell carcinoma (ChiCTR) - P2 | N=200 | Sponsor: Chongqing University Cancer Hospital; Chongqing University Cancer Hospital

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

Vorolanib combined with everolimus for targeted therapy of patients with advanced second/third-line liver cancer with TSC1/2 mutation: A single-arm, Phase II exploratory clinical study (ChiCTR) - P2 | N=47 | Recruiting | Sponsor: Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences

New P2 trial • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • TSC1

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