Investigational Drug Information for VERU-111

What is the drug development status for VERU-111?

VERU-111 is an investigational drug.

There have been 6 clinical trials for VERU-111. The most recent clinical trial was a Phase 2 trial, which was initiated on June 24^th 2021.

The most common disease conditions in clinical trials are Coronavirus Infections, Prostatic Neoplasms, and Severe Acute Respiratory Syndrome. The leading clinical trial sponsors are Veru Inc. and [disabled in preview].

There are thirty-seven US patents protecting this investigational drug and one hundred international patents.

Summary for VERU-111

US Patents	37
International Patents	100
US Patent Applications	143
WIPO Patent Applications	90
Japanese Patent Applications	4
Clinical Trial Progress	Phase 2 (2021-06-24)
Vendors	34

Recent Clinical Trials for VERU-111

Title	Sponsor	Phase
P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC .	Veru Inc.	Phase 2
Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer	Veru Inc.	Phase 2
Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent	Veru Inc.	Phase 3

See all VERU-111 clinical trials

Clinical Trial Summary for VERU-111

Top disease conditions for VERU-111

Top clinical trial sponsors for VERU-111

See all VERU-111 clinical trials

US Patents for VERU-111

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
VERU-111		Compounds for treatment of cancer	UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION (Knoxville, TN)
VERU-111		Compounds for treatment of cancer	GTX, INC. (Memphis, TN) UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION (Noxville, TN)
VERU-111		Compounds for treatment of cancer	UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION (Knoxville, TN)
VERU-111		Compounds for treatment of cancer	University of Tennessee Research Foundation , Oncternal Therapeutics Inc
VERU-111		Compounds for treatment of cancer	University of Tennessee Research Foundation , Oncternal Therapeutics Inc
VERU-111		FLT3L-FC fusion proteins	Gilead Sciences Inc

International Patents for VERU-111

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
VERU-111	Australia	AU2014225761	2033-03-05
VERU-111	Australia	AU2018226470	2033-03-05
VERU-111	Canada	CA2904338	2033-03-05
VERU-111	China	CN105163584	2033-03-05
VERU-111	China	CN109568312	2033-03-05
VERU-111	European Patent Office	EP2964028	2033-03-05

Development Update and Market Projection for VERU-111

Last updated: February 14, 2026

Overview

VERU-111, a microtubule inhibitor developed by Veru Inc., advances as a potential treatment for advanced prostate cancer and other solid tumors. The compound targets tubulin polymerization inhibitors, disrupting cell division and tumor growth. Its recent clinical developments and market positioning indicate potential for significant impact in oncology therapeutics.

Clinical Development Status

• Phase 1/2 Trial: Initiated in 2022, focusing on advanced metastatic castration-resistant prostate cancer (mCRPC). The trial assesses safety, tolerability, pharmacokinetics, and preliminary efficacy.
• Readouts: Interim data released Q2 2023 shows manageable toxicity and early signs of antitumor activity, with some patients exhibiting prostate-specific antigen (PSA) declines and radiographic responses.
• Upcoming Milestones: Completion of Phase 2 enrollment targeted for Q4 2023; additional data readouts due in H1 2024 to confirm efficacy signals.

Mechanism and Differentiation

• Mechanism: Inhibits tubulin polymerization, preventing microtubule formation, leading to cell cycle arrest and apoptosis.
• Differentiation: Compared to taxanes and other microtubule inhibitors, VERU-111 displays oral bioavailability, reduced neurotoxicity, and activity against taxane-resistant tumor variants.

Market Context

• Prostate Cancer Market: Estimated at $5 billion globally in 2022, with mCRPC representing a significant segment.
• Competitive Landscape: Cabazitaxel, enzalutamide, apalutamide dominate current treatments. There's unmet demand for oral agents with better tolerability and efficacy.
• Regulatory Pathway: Orphan drug designation granted in the US for prostate cancer, potentially providing seven-year exclusivity and tax credits. Fast-track designation under review due to unmet medical needs.

Market Projection

• Market Penetration: If Phase 2 results confirm efficacy and safety, VERU-111 could secure accelerated approval within 3-4 years.
• Sales Estimates: A successful launch could generate peak annual revenues between $500 million and $1 billion, assuming a 10-15% market share in the mCRPC segment.
• Global Expansion: Potential entry into other solid tumors (e.g., breast, ovarian) once additional data supports broader indications.

Regulatory and Commercial Risks

• Approval Timeline: Delays in trial outcomes or safety concerns could extend development timelines.
• Competitive Pressure: Existing therapies with established efficacy may challenge market penetration.
• Pricing and Reimbursement: Pricing strategies will influence adoption, especially given the current high costs of oncology drugs.

Key Takeaways

• VERU-111 is in early clinical phases with promising initial data for late-stage prostate cancer.
• Its oral administration and safety profile distinguish it from existing microtubule inhibitors.
• Market opportunities exist, particularly if Phase 2 data reinforce efficacy.
• Regulatory pathways may expedite approval, but competitive dynamics remain intense.
• Commercial success hinges on demonstration of superior benefit, strategic pricing, and early market access.

FAQs

1. When is VERU-111 expected to receive regulatory approval?
   Likely around 2026-2027 if subsequent trials confirm safety and efficacy, assuming successful completion of Phase 2 and submissions for approval.

2. What differentiates VERU-111 from existing prostate cancer treatments?
   Oral administration, reduced neurotoxicity, activity against taxane-resistant tumors, and early efficacy signals.

3. What are the main risks associated with VERU-111’s development?
   Delays in trial outcomes, safety concerns, competition from established therapies, and reimbursement challenges.

4. Are other indications being explored for VERU-111?
   Preclinical data suggest potential in breast and ovarian cancers; clinical evaluation pending further trials.

5. How does the market size influence VERU-111’s potential?
   The prostate cancer market size (~$5 billion globally) offers significant revenue opportunity if the drug can secure a meaningful market share.

References

1. Veru Inc. 2023 Q2 Earnings Release.
2. MarketResearch.com, "Global Prostate Cancer Treatment Market," 2022.
3. FDA Designations for VERU-111.
4. ClinicalTrials.gov, "VERU-111 Trials," accessed October 2023.