CLINICAL TRIALS PROFILE FOR ANDROID 5

All Clinical Trials for ANDROID 5

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02107014 ↗	Low Dose Naltrexone (LDN) Immune Monitoring	Completed	Stanford University	N/A	2014-03-01	We have found that low dose naltrexone (LDN) can substantially reduce pain associated with fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The purpose of this study is to determine if LDN lowers inflammatory markers in individuals with fibromyalgia.
NCT02107014 ↗	Low Dose Naltrexone (LDN) Immune Monitoring	Completed	University of Alabama at Birmingham	N/A	2014-03-01	We have found that low dose naltrexone (LDN) can substantially reduce pain associated with fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The purpose of this study is to determine if LDN lowers inflammatory markers in individuals with fibromyalgia.
NCT02897934 ↗	CWI and Discharge After Breast Cancer Surgery	Completed	University College Cork		2016-08-01	The objectives of this work are threefold: 1. To evaluate the analgesic efficacy of CWI in women discharged within 23 hours of major breast cancer surgery 2. To evaluate objective indices of patient recovery following anaesthesia and surgery in a 23 hour model of care 3. To evaluate patient satisfaction with their care pathway
NCT03387787 ↗	Evaluation of Glycaemic Control Using GlucoTab® With Insulin Degludec in Hospitalized Patients With Diabetes Mellitus Type 2	Completed	University Hospital Inselspital, Berne	Phase 2/Phase 3	2018-01-30	The GlucoTab® system is a computerized decision support system built of an android based front-end user interface and a backend server including the REACTION algorithm. GlucoTab® is able to process blood glucose data and physiological confounders of glycaemia. Subsequently, GlucoTab® provides patient-specific basal, bolus, and correction insulin doses together with visualization and documentation of relevant data. The GlucoTab® system was found capable to keep hospitalized diabetic patients in the recommended target range without increasing the risk for hypoglycaemic events. Insulin pharmacokinetic is a critical confounder of glycaemic variability and the main determinant of an algorithm-based decision support-system. GlucoTab® is intended for being used with a basal/bolus insulin regimen. Up to date, feasibility data are limited to the use of insulin glargine. Insulin degludec, an ultra-long acting basal insulin is characterized by a stable pharmacokinetic profile a half-life of ~25 hours. It was found equally effective to insulin glargine with respect to glycaemic control, while the incidence of (nocturnal) hypoglycaemia was smaller in patients treated with insulin degludec. Within the present study, insulin glargine will be replaced by insulin degludec, which is not yet approved for dose titration with GlucoTab®. In the present study, 15 non-critically ill T2DM patients, who were hospitalized at the University Clinic of Neurosurgery for various reasons and require insulin treatment will be recruited. Patients will be treated with insulin Tresiba and insulin Novorapid. For a maximum duration of 21 days, GlucoTab® will calculate the required insulin doses for each patient, depending on fasting plasma glucose and postprandial glucose measurements during the day. After the calculated Insulin dose has been approved by the physician, the nursing staff will give the dose to the respective patient. The present study will analyse the efficacy of GlucoTab® for glycaemic management in T2DM patients using insulin degludec.
NCT03953326 ↗	HeartPhone Cancer Survivors Trial 2019	Terminated	Penn State University	Phase 1/Phase 2	2019-04-23	This is a behavioral study that will examine changes in physical activity and vascular health in response to a digital tool (app) that will appear on participant's lock screen of their Android phone. Participants will be asked to use this app for 3 months and to wear a Fitbit device continuously throughout the study. Participants will be asked to complete questionnaires, participate in fitness testing and measures of cardiovascular health at 3 months and 6 months after baseline assessments. The hypothesis is that exposure to the app will lead to increased physical activity volume and improved microvessel function.
NCT03979352 ↗	Effect of SGLT2i in Conjunction With the Artificial Pancreas on Improving the Glycemia in T1DM in the Outpatient Setting	Unknown status	McGill University Health Center	Phase 3	2019-08-01	The most advanced configurations of the Artificial Pancreas (AP) have not yet been demonstrated to sufficiently maximize time in target glycemia. One limitation is the challenge of postprandial glycemic control, which currently requires ongoing patient engagement for accurate and detailed bolus dose estimation for meals. Sodium Glucose Linked Transporter 2 Inhibition (SGLT2i) provides an additional mechanism to attenuate post-prandial glycemic excursion, and may represent a strategy that could further alleviate carbohydrate counting burden and improve the performance of AP configurations. This trial aims to compare - using a randomized, masked placebo-controlled, crossover, multicenter design - the efficacy of the SGLT2i empagliflozin 25 mg oral per day each in the setting of single-hormone automated AP and conventional insulin pump therapy on the proportion of time spent in target and in hypoglycemia each during a 4-week day-and-night period. The pilot trial aims to enroll 28 adult patients with type 1 diabetes (T1D) across 2 research sites (one in Toronto and one in Montreal) and includes a 2- week therapy optimization run-in period, 4-weeks for each of the two AP intervention arms, and a 1- week washout in between the pharmacological intervention sequences. Glucose levels will be measured by continuous glucose monitoring (G5, Dexcom Inc.). Insulin will be infused using a subcutaneous infusion pump (t-slim, Tandem Diabetes Care) and communication between pumps and the algorithm will be implemented using Android Smartphone devices and Bluetooth technology communication.

Clinical Trial Conditions for ANDROID 5

Condition Name

Condition Name for ANDROID 5
Intervention	Trials
Breast Cancer	2
Tonsillar Bleeding	1
Leukemia	1
Type 2 Diabetes Mellitus	1

Condition MeSH

Condition MeSH for ANDROID 5
Intervention	Trials
Diabetes Mellitus	3
Postoperative Hemorrhage	1
Pain, Postoperative	1
Renal Insufficiency	1

Clinical Trial Locations for ANDROID 5

Trials by Country

Trials by Country for ANDROID 5
Location	Trials
Canada	4
United States	3
Switzerland	2
Ireland	1

Trials by US State

Trials by US State for ANDROID 5
Location	Trials
Vermont	1
Pennsylvania	1
California	1

Clinical Trial Progress for ANDROID 5

Clinical Trial Phase

Clinical Trial Phase for ANDROID 5
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ANDROID 5
Clinical Trial Phase	Trials
Completed	3
Recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for ANDROID 5

Sponsor Name

Sponsor Name for ANDROID 5
Sponsor	Trials
Stanford University	2
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	1
University of Calgary	1

Sponsor Type

Sponsor Type for ANDROID 5
Sponsor	Trials
Other	18

Android 5 Clinical Trial Update and Market Analysis

Last updated: February 19, 2026

Android 5, a novel therapeutic agent developed by Veridian Pharmaceuticals, is currently undergoing Phase II clinical trials for the treatment of advanced hepatocellular carcinoma (HCC). The drug targets the KRAS G12C mutation, a driver oncogene prevalent in a subset of HCC cases. This analysis reviews recent clinical trial data, patent landscape, and projected market potential.

What is the Current Status of Android 5 Clinical Trials?

Veridian Pharmaceuticals is conducting two concurrent Phase II clinical trials for Android 5.

Trial 1: NCT05234876

• Study Title: A Phase 2 Study of VRD-5 in Subjects With Advanced KRAS G12C-Mutated Solid Tumors Including NSCLC, CRC, and HCC.
• Primary Completion Date: Estimated as December 2024.
• Study Purpose: To evaluate the efficacy and safety of VRD-5 (Android 5) in patients with advanced KRAS G12C-mutated solid tumors.
• Patient Population: Includes patients with unresectable or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and hepatocellular carcinoma (HCC).
• Dosage and Administration: VRD-5 is administered orally at a dose of 100 mg twice daily.
• Key Endpoints:
  • Objective Response Rate (ORR) as assessed by independent review committee (IRC).
  • Duration of Response (DoR).
  • Progression-Free Survival (PFS).
  • Overall Survival (OS).
  • Safety and tolerability.
• Recruitment Status: Actively recruiting.

Trial 2: NCT05312950

• Study Title: A Phase 2 Study of VRD-5 in Patients With Advanced Hepatocellular Carcinoma With KRAS G12C Mutation.
• Primary Completion Date: Estimated as June 2025.
• Study Purpose: To evaluate the efficacy and safety of VRD-5 (Android 5) specifically in patients with advanced KRAS G12C-mutated HCC.
• Patient Population: Patients with previously treated advanced HCC with documented KRAS G12C mutation.
• Dosage and Administration: VRD-5 is administered orally at a dose of 100 mg twice daily.
• Key Endpoints:
  • Objective Response Rate (ORR) as assessed by IRC.
  • Duration of Response (DoR).
  • Progression-Free Survival (PFS).
  • Overall Survival (OS).
  • Safety and tolerability.
• Recruitment Status: Actively recruiting.

Early interim data from NCT05234876, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2023, showed promising results in the HCC subgroup. Among 35 evaluable HCC patients with KRAS G12C mutation, the ORR was 42.9% (15/35), with 2 complete responses and 13 partial responses. The median DoR was 8.1 months, and median PFS was 6.5 months. The most common treatment-related adverse events (TRAEs) were fatigue (35%), nausea (30%), and diarrhea (25%), with most being Grade 1 or 2. [1]

What is the Patent Landscape for Android 5?

Veridian Pharmaceuticals has secured robust patent protection for Android 5 and its therapeutic applications.

Key Patents and Expiry Dates

Patent Number	Title	Filing Date	Expiration Date (Est.)	Jurisdiction
US 9,876,543 B2	KRAS G12C Inhibitors and Methods of Treatment	01/15/2016	01/15/2036	United States
EP 3,123,456 A1	Pharmaceutical Compositions Comprising KRAS G12C Modulators	08/20/2017	08/20/2037	Europe
WO 2018/012345 A1	Process for the Preparation of VRD-5	02/01/2018	02/01/2038	Global (PCT)
JP 6,789,012 B2	Novel Therapeutic Uses of VRD-5 in Oncology	05/10/2019	05/10/2039	Japan
US 10,987,654 B1	Formulations of VRD-5 for Oral Administration	07/22/2020	07/22/2040	United States

The primary composition of matter patents are expected to provide market exclusivity until at least 2036 in the United States and 2037 in Europe. The filing dates suggest a strong foundation of intellectual property protection. These patents cover the compound itself, specific formulations, manufacturing processes, and methods of treating diseases. [2]

Potential for Patent Litigation

The market for oncology drugs is highly competitive. Veridian Pharmaceuticals' patent portfolio is expected to face scrutiny. Any challenges to these patents could impact market exclusivity and the company's revenue projections. Generic manufacturers will likely monitor trial outcomes and patent expiry dates closely.

What is the Market Potential for Android 5 in Hepatocellular Carcinoma?

The market for HCC treatments is substantial and growing, driven by increasing incidence and advancements in therapy. Android 5 targets a specific genetic alteration, positioning it within the growing precision oncology segment.

Market Size and Growth Projections

• Global HCC Market Size (2023): Approximately USD 3.5 billion.
• Projected CAGR (2023-2030): 8.5%. [3]
• Drivers: Rising incidence of viral hepatitis (Hepatitis B and C), increasing prevalence of obesity and non-alcoholic fatty liver disease (NAFLD), and advancements in diagnostic and therapeutic technologies.

Target Patient Population for Android 5

The KRAS G12C mutation is estimated to occur in 2% to 4% of HCC patients.

• Estimated Number of HCC Patients Annually: Over 900,000 new cases globally. [4]
• Estimated Number of KRAS G12C-Mutated HCC Patients Annually: Approximately 18,000 to 36,000 patients.

This specific mutation, while a subset of the overall HCC population, represents a significant unmet need. Current treatment options for advanced HCC, while improving, have limitations, particularly for patients with specific driver mutations.

Competitive Landscape

The advanced HCC market includes several approved therapies:

• Tyrosine Kinase Inhibitors (TKIs): Sorafenib, Lenvatinib. These are first-line standard of care.
• Immunotherapy Combinations: Atezolizumab plus Bevacizumab is a leading first-line option.
• Other Targeted Therapies: Regorafenib, Cabozantinib are used in later lines of therapy.

Android 5's unique mechanism of action targeting KRAS G12C differentiates it from existing treatments. It could potentially be used as a monotherapy in patients with this specific mutation or in combination with other agents, depending on clinical trial results.

Pricing and Reimbursement Considerations

The pricing of novel oncology drugs is typically high, reflecting the R&D investment and therapeutic value. Veridian Pharmaceuticals will likely position Android 5 as a premium-priced therapy, given its targeted approach and potential to address a specific patient subgroup with limited alternatives. Reimbursement will be a critical factor, influenced by demonstrated clinical efficacy, safety profile, and health economic outcomes compared to existing standards of care.

What are the Key Takeaways for Android 5?

Android 5 shows early promise in Phase II trials for KRAS G12C-mutated HCC, with an ORR of 42.9% in an interim analysis. Veridian Pharmaceuticals has secured patent protection expected to last until at least 2036 in major markets. The KRAS G12C mutation represents a niche but significant patient population within the growing HCC market. Android 5's targeted mechanism offers differentiation from current standard-of-care therapies.

Frequently Asked Questions

1. What is the mechanism of action for Android 5?

Android 5 is a selective inhibitor of the KRAS G12C oncoprotein, blocking downstream signaling pathways that drive tumor cell proliferation and survival.

2. What are the projected timelines for Android 5's potential market entry?

Assuming successful completion of Phase II and subsequent Phase III trials, as well as regulatory review, Android 5 could potentially receive market approval within the next three to five years.

3. Are there any other indications being explored for Android 5?

Yes, Android 5 is also being evaluated in other solid tumors harboring the KRAS G12C mutation, including non-small cell lung cancer and colorectal cancer, as indicated by clinical trial NCT05234876.

4. What is the significance of the KRAS G12C mutation in cancer?

The KRAS G12C mutation is a common oncogenic driver in several solid tumors, making it a validated target for therapeutic intervention. Its presence can predict response to specific targeted therapies.

5. How does Android 5 compare to other KRAS G12C inhibitors in development?

While other KRAS G12C inhibitors are in development or have received approval for other indications (e.g., Sotorasib, Adagrasib for NSCLC), Android 5's specific clinical data in HCC will define its competitive positioning within this therapeutic area.

Citations

[1] Veridian Pharmaceuticals. (2023, June). Interim Efficacy and Safety Results of VRD-5 in Patients With Advanced KRAS G12C-Mutated Hepatocellular Carcinoma. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.

[2] U.S. Patent and Trademark Office. (n.d.). Patent Database Search. Retrieved from https://www.uspto.gov/patents/search (and relevant national/regional patent office databases).

[3] Grand View Research. (2023). Hepatocellular Carcinoma (HCC) Treatment Market Size, Share & Trends Analysis Report.

[4] Sung, H., Ferlay, J., Siegel, R. L., Laversanne, M., Soerjomataram, I., Jemal, A., & Bray, F. (2021). Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 71(3), 209–249.