Investigational Drug Information for GDC-9545

What is the drug development status for GDC-9545?

GDC-9545 is an investigational drug.

There have been 15 clinical trials for GDC-9545. The most recent clinical trial was a Phase 1 trial, which was initiated on June 1^st 2022.

The most common disease conditions in clinical trials are Breast Neoplasms, Endometrial Neoplasms, and [disabled in preview]. The leading clinical trial sponsors are Hoffmann-La Roche, Genentech, Inc., and MedSIR.

There is one US patent protecting this investigational drug and thirty-one international patents.

Summary for GDC-9545

US Patents	1
International Patents	31
US Patent Applications	97
WIPO Patent Applications	119
Japanese Patent Applications	60
Clinical Trial Progress	Phase 1 (2022-06-01)
Vendors	27

Recent Clinical Trials for GDC-9545

Title	Sponsor	Phase
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)	Hoffmann-La Roche	Phase 3
A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population	MedSIR	Phase 2
Preoperative Window of Opportunity Study With Giredestrant (GDC-9545) or Tamoxifen in Premenopausal Women With ER[+]/HER2[-] & Ki67≥10% Early Breast Cancer	MedSIR	Phase 2

See all GDC-9545 clinical trials

Clinical Trial Summary for GDC-9545

Top disease conditions for GDC-9545

Top clinical trial sponsors for GDC-9545

See all GDC-9545 clinical trials

US Patents for GDC-9545

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
GDC-9545		Tetrahydro-pyrido[3,4-b]indole estrogen receptor modulators and uses thereof	Genentech, Inc. (South San Francisco, CA)

International Patents for GDC-9545

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
GDC-9545	Argentina	AR103081	2034-12-18
GDC-9545	Australia	AU2015367509	2034-12-18
GDC-9545	Australia	AU2020200407	2034-12-18
GDC-9545	Brazil	BR112017007662	2034-12-18

GDC-9545 (Giredestrant): A Promising Drug Candidate in the SERD Therapeutics Market

Introduction to GDC-9545 (Giredestrant)

GDC-9545, also known as giredestrant, is a drug candidate under development by F. Hoffmann-La Roche Ltd for the treatment of various types of cancer, particularly those involving estrogen receptor-positive (ER+) tumors. This drug belongs to the class of selective estrogen receptor degraders (SERDs), which are designed to target and degrade the estrogen receptor, a key factor in the growth and proliferation of certain cancer cells.

Mechanism of Action

Giredestrant acts as a nonsteroidal, oral SERD, targeting the estrogen receptor (ER) to inhibit the growth of ER-positive cancer cells. Unlike traditional estrogen receptor antagonists, SERDs like giredestrant not only block the receptor's activity but also induce its degradation, thereby providing a more potent and sustained therapeutic effect[3][4].

Indications

GDC-9545 is being developed for several indications, including:

• Estrogen Receptor Positive and HER2 Negative Metastatic Breast Cancer: This is one of the primary targets for giredestrant, given the high prevalence of ER+ and HER2- breast cancer.
• HER2 Positive, Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer: The drug is also being explored for its efficacy in treating HER2+ and ER+ breast cancers.
• Neoadjuvant ER Positive Breast Cancer: Giredestrant is under investigation for its potential use in the neoadjuvant setting to treat early-stage ER+ breast cancer.
• Endometrial Cancer: Additionally, the drug is being evaluated for its therapeutic potential in endometrial cancer[1][3].

Development Updates

Improvement Over Predecessor

GDC-9545 was designed to overcome the limitations of its predecessor, GDC-0927, which had issues with poor absorption and high pill burden. Giredestrant has shown improved pharmacokinetic properties, including better absorption and clearance, making it a more viable candidate for clinical use[4].

Pharmacokinetic/Pharmacodynamic Modeling

Physiologically-based pharmacokinetic/pharmacodynamic (PBPK-PD) models have been developed to characterize the relationship between the oral exposure of giredestrant and its antitumor activity. These models have been used to predict the human efficacious dose and have demonstrated that giredestrant requires a lower dose compared to GDC-0927 due to its improved pharmacokinetic profile[4].

Market Projections

Global SERD Therapeutics Market

The global SERD therapeutics market is experiencing significant growth, driven by the increasing prevalence of breast cancer and the advancements in biopharmaceutical technologies. Here are some key market projections:

• Market Size: The global SERD therapeutics market was valued at $1.50 billion in 2022 and is expected to reach $6.38 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 17.5% from 2023 to 2031[2][5].
• Regional Growth: North America is currently the major revenue holder in this market, followed closely by Europe. However, the Asia-Pacific region is projected to show significant growth due to the rapid adoption of new technologies and the expansion of SERD therapeutic industries[2][5].

Competitive Landscape

Giredestrant is part of a competitive landscape that includes other SERD candidates such as Faslodex, Elacestrant, Camizestrant (AZD9833), and Imlunestrant (LY3484356). The market is highly competitive, with multiple companies investing heavily in research and development to bring innovative therapies to the market[2].

Route of Administration

Giredestrant is administered orally, which is a significant advantage over other SERDs that may require intramuscular or infusion routes. The oral route enhances patient compliance and convenience, making it a more appealing option for long-term treatment[1][3].

Regulatory and Clinical Pathway

The development of giredestrant involves a rigorous clinical and regulatory pathway. GlobalData's analysis includes factors such as patent law, regulatory approval processes, and cash flow projections to evaluate the drug's potential success. The likelihood of approval and phase transition success rates are closely monitored to predict the drug's future in the market[1][3].

Future Outlook

Given its improved pharmacokinetic profile and potent therapeutic action, giredestrant is poised to become a significant player in the SERD therapeutics market. The drug's ability to target and degrade the estrogen receptor makes it a promising treatment option for patients with ER-positive cancers, particularly those who have developed resistance to other therapies.

Key Takeaways

• Mechanism of Action: Giredestrant acts as a selective estrogen receptor degrader, targeting and degrading the estrogen receptor.
• Indications: The drug is being developed for various types of breast cancer and endometrial cancer.
• Development Updates: Giredestrant has shown improved pharmacokinetic properties compared to its predecessor, GDC-0927.
• Market Projections: The global SERD therapeutics market is expected to grow significantly, with giredestrant contributing to this growth.
• Competitive Landscape: The market is competitive, with multiple SERD candidates under development.
• Route of Administration: Giredestrant is administered orally, enhancing patient compliance.

FAQs

What is GDC-9545 (Giredestrant)?

GDC-9545, or giredestrant, is a drug candidate under development as a selective estrogen receptor degrader (SERD) for the treatment of various cancers, including estrogen receptor-positive breast cancer and endometrial cancer.

What are the key indications for Giredestrant?

Giredestrant is being developed for estrogen receptor-positive and HER2-negative metastatic breast cancer, HER2-positive and estrogen receptor-positive locally advanced or metastatic breast cancer, neoadjuvant ER-positive breast cancer, and endometrial cancer.

How does Giredestrant differ from its predecessor, GDC-0927?

Giredestrant has improved pharmacokinetic properties, including better absorption and clearance, compared to GDC-0927, which had issues with poor absorption and high pill burden.

What is the projected market size for the global SERD therapeutics market by 2031?

The global SERD therapeutics market is expected to reach $6.38 billion by 2031, growing at a CAGR of 17.5% from 2023 to 2031.

Which regions are expected to drive the growth of the SERD therapeutics market?

North America and Europe are currently the major revenue holders, but the Asia-Pacific region is projected to show significant growth due to the rapid adoption of new technologies and the expansion of SERD therapeutic industries.

What is the route of administration for Giredestrant?

Giredestrant is administered orally, which enhances patient compliance and convenience.

Sources

1. GlobalData, "Giredestrant in Solid Tumor Drug Details: GDC-9545 (RG-6171)".
2. GlobeNewswire, "SERD Therapeutics Market Recording a Promising CAGR of 17.5% from 2023-2031".
3. GlobalData, "Net Present Value Model: F. Hoffmann-La Roche Ltd's Giredestrant".
4. PubMed, "Physiologically-based pharmacokinetic/pharmacodynamic modeling of GDC-9545".
5. InsightAce Analytic, "SERD Therapeutics Market Share, Size, Growth and Forecast to 2031".