Investigational Drug Information for GDC-0084

What is the drug development status for GDC-0084?

GDC-0084 is an investigational drug.

There have been 9 clinical trials for GDC-0084. The most recent clinical trial was a Phase 1 trial, which was initiated on July 30^th 2019.

The most common disease conditions in clinical trials are Glioma, Glioblastoma, and Brain Neoplasms. The leading clinical trial sponsors are Kazia Therapeutics Limited, Genentech, Inc., and Kazia Therapeutics.

There are one hundred and fifty-five US patents protecting this investigational drug and three hundred and seventy international patents.

Summary for GDC-0084

US Patents	155
International Patents	370
US Patent Applications	354
WIPO Patent Applications	207
Japanese Patent Applications	13
Clinical Trial Progress	Phase 1 (2019-07-30)
Vendors	52

Recent Clinical Trials for GDC-0084

Title	Sponsor	Phase
Combination Therapy for the Treatment of Diffuse Midline Gliomas	Mithil Prasad Foundation	Phase 2
Combination Therapy for the Treatment of Diffuse Midline Gliomas	Storm the Heavens Fund	Phase 2
Combination Therapy for the Treatment of Diffuse Midline Gliomas	The Chad-Tough Defeat DIPG Foundation	Phase 2

See all GDC-0084 clinical trials

Clinical Trial Summary for GDC-0084

Top disease conditions for GDC-0084

Top clinical trial sponsors for GDC-0084

See all GDC-0084 clinical trials

US Patents for GDC-0084

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
GDC-0084		Combination of PI3K-inhibitors	BAYER PHARMA AKTIENGESELLSCHAFT (Berlin, DE)
GDC-0084		Quinazoline compounds	Gilead Sciences, Inc. (Foster City, CA) Institute of Organic Chemistry and Biochemistry of the AS CR, V.V.I. (CZ)
GDC-0084		HIV inhibitor compounds	Gilead Sciences, Inc. (Foster City, CA)
GDC-0084		Prognostic assay for squamous cell lung carcinoma	Life Technologies Corp

International Patents for GDC-0084

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
GDC-0084	European Patent Office	EP3077003	2033-12-03
GDC-0084	World Intellectual Property Organization (WIPO)	WO2015082378	2033-12-03
GDC-0084	Argentina	AR103252	2034-12-24
GDC-0084	Australia	AU2015371198	2034-12-24

Development Update and Market Projection for GDC-0084

Last updated: February 12, 2026

Summary

GDC-0084, developed by Genentech/Roche, is a brain-penetrant, small-molecule PI3K inhibitor primarily targeting glioblastoma multiforme (GBM). As of early 2023, GDC-0084 remains in clinical development with limited publicly available trial data. Market projections suggest a significant opportunity based on the unmet needs in GBM, though regulatory, competitive, and clinical challenges could restrict near-term commercialization.

Development Status

• Clinical Trials
  GDC-0084 entered phase I trials in 2017. The trial focuses on safety, dosing, and pharmacokinetics in recurrent high-grade gliomas, including GBM. Data released from 2019 indicate manageable safety profiles and preliminary signs of activity.
  As of 2023, the compound has not progressed to phase II/III registration studies publicly. No further trial results have been announced, indicating possible delays or strategic reevaluations.

• Mechanism of Action
  GDC-0084 inhibits PI3K pathway activation. Its design allows for blood-brain barrier penetration, addressing a common obstacle in brain tumor therapeutics.

• Regulatory Status
  No formal filings for approval or Fast Track designations with the FDA are publicly documented. The development context indicates ongoing preclinical or early-phase clinical assessment.

Market Overview

• Glioblastoma Market Size
  The global GBM market is projected to reach approximately $450 million by 2028, growing at a CAGR of around 8% (Source: GlobalData). This growth is driven by increased incidence, limited effective therapies, and evolving treatment regimens.

• Current Standard of Care
  Temozolomide combined with radiotherapy remains the first-line treatment. Post-progression options include bevacizumab and tumor-treating fields. Despite these advancements, median survival remains approximately 15 months.

• Unmet Need
  GBM’s aggressive nature and resistance to existing treatments highlight a significant unmet medical need. Targeted therapies that penetrate the blood-brain barrier and inhibit oncogenic pathways have high potential if clinical efficacy is demonstrated.

Market Entry and Competitive Landscape

• Potential Market Penetration
  If GDC-0084 demonstrates safety and efficacy in phase II/III trials, it could secure a niche in recurrent GBM management. Approximate market share in first-line or recurrent settings could reach 15-20%, generating annual revenues from hundreds of millions to over a billion dollars.

• Competitive Drugs

  • Regorafenib (Stivarga): Approved for recurrent GBM; captures a small market share.
  • Vistograft (Vismodegib): Investigational in gliomas.
  • Other PI3K inhibitors (e.g., copanlisib) lack brain penetration, limiting their use in GBM.

• Development Risks

  • Limited early trial data introduces uncertainty regarding efficacy.
  • Potential toxicities such as hyperglycemia, rash, or gastrointestinal effects.
  • High regulatory hurdles due to the aggressive disease course and historical trial failures in GBM.

Financial and Strategic Considerations

• Investment Timeline
  Assuming positive phase Ib/II results by 2024, progression to phase III could occur by 2025-2026, with potential approval around 2028-2029.

• Partnership Opportunities
  Larger pharma entities with oncology portfolios may seek licensing or co-development deals, particularly if early efficacy signals are observed.

• Market Risks
  Competition from emerging immunotherapies and tumor-treating radiotherapy modalities could impact market capture.

Key Takeaways

• GDC-0084 remains in early-stage clinical development with limited published data.
• The GBM market is sizable with high unmet need, but challenging for novel targeted therapies due to difficulties establishing efficacy.
• Market projection depends critically on clinical efficacy, safety profile, and regulatory pathway success.
• Strategic partnerships and early clinical results will influence commercialization potential.
• Competitive landscape is intense, emphasizing the importance of rapid demonstration of therapeutic benefit.

FAQs

1. What are the main hurdles for GDC-0084 to reach market approval?
   Demonstrating clear efficacy in phase II or III trials, managing toxicity profiles, and navigating regulatory requirements given the complexity of brain tumor trials.

2. How does GDC-0084 compare with other PI3K inhibitors?
   It uniquely penetrates the blood-brain barrier, unlike many systemic PI3K inhibitors, which limits their use in brain cancers.

3. When could GDC-0084 potentially be approved?
   If early efficacy is positive, approval could occur around 2028-2029, contingent on successful phase III trials.

4. What is the outlook for GBM therapeutics generally?
   The market remains difficult due to the disease’s aggressiveness, with no current standard targeted therapy beyond standard chemoradiation and supportive care.

5. What factors could accelerate GDC-0084’s market entry?
   Positive early trial results and strategic partnerships could speed development and approval processes.

Citations

[1] GlobalData, "Glioblastoma Multiforme Market Analysis," 2022.
[2] ClinicalTrials.gov, "GDC-0084 Clinical Trials," accessed 2023.
[3] The American Brain Tumor Association, "Glioblastoma Facts," 2023.