CLINICAL TRIALS PROFILE FOR TRILACICLIB DIHYDROCHLORIDE

All Clinical Trials for trilaciclib dihydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02499770 ↗	Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)	Completed	G1 Therapeutics, Inc.	Phase 1/Phase 2	2015-06-26	This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.
NCT02514447 ↗	Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy	Active, not recruiting	G1 Therapeutics, Inc.	Phase 1/Phase 2	2015-10-05	This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to topotecan in patients previously treated for extensive-stage SCLC. The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. The open-label portion enrolled 32 patients and the randomized portion will enroll approximately 90 patients.
NCT02978716 ↗	Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)	Active, not recruiting	G1 Therapeutics, Inc.	Phase 2	2017-02-07	This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for patients with metastatic triple negative breast cancer. The study is open-label and approximately 90 patients will be randomly assigned (1:1:1 fashion) to 1 of the 3 following treatment groups: - Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=30) - Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day cycles (n=30) - Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of 21-day cycles (n=30) The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit.
NCT03041311 ↗	Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Extensive Stage Small Cell Lung Cancer (SCLC)	Active, not recruiting	G1 Therapeutics, Inc.	Phase 2	2017-04-07	This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing antitumor efficacy when administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study is a randomized, double-blinded, placebo-controlled design. The study will include 3 study phases: Screening Phase,Treatment Phase (induction part + maintenance part), and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 100 patients will be enrolled in the study.

Clinical Trial Conditions for trilaciclib dihydrochloride

Condition Name

Condition Name for trilaciclib dihydrochloride
Intervention	Trials
Breast Cancer	4
Myelosuppression	4
Extensive-stage Small-cell Lung Cancer	3
Triple Negative Breast Cancer	3

Condition MeSH

Condition MeSH for trilaciclib dihydrochloride
Intervention	Trials
Lung Neoplasms	9
Small Cell Lung Carcinoma	8
Breast Neoplasms	8
Carcinoma, Non-Small-Cell Lung	7

Clinical Trial Locations for trilaciclib dihydrochloride

Trials by Country

Trials by Country for trilaciclib dihydrochloride
Location	Trials
United States	123
China	27
Spain	10
United Kingdom	6
Ukraine	6

Trials by US State

Trials by US State for trilaciclib dihydrochloride
Location	Trials
California	8
Texas	8
Florida	7
Missouri	6
Virginia	6

Clinical Trial Progress for trilaciclib dihydrochloride

Clinical Trial Phase

Clinical Trial Phase for trilaciclib dihydrochloride
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	18
Phase 4	2

Clinical Trial Status

Clinical Trial Status for trilaciclib dihydrochloride
Clinical Trial Phase	Trials
Recruiting	20
NOT_YET_RECRUITING	8
Not yet recruiting	7

Clinical Trial Sponsors for trilaciclib dihydrochloride

Sponsor Name

Sponsor Name for trilaciclib dihydrochloride
Sponsor	Trials
G1 Therapeutics, Inc.	15
Jiangsu Simcere Pharmaceutical Co., Ltd.	4
The First Affiliated Hospital of Xiamen University	2

Sponsor Type

Sponsor Type for trilaciclib dihydrochloride
Sponsor	Trials
Other	34
Industry	20
OTHER_GOV	1

Clinical Trials Update, Market Analysis, and Projection for Trilaciclib Dihydrochloride

Last updated: October 28, 2025

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Introduction

Trilaciclib dihydrochloride, a first-in-class cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, has garnered significant attention within oncology therapeutics, primarily due to its unique approach to preserving bone marrow function during chemotherapy. As the pharmaceutical landscape evolves, understanding the recent clinical developments, market dynamics, and future projections for trilaciclib is essential for stakeholders, including investors, healthcare providers, and pharmaceutical companies.

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Clinical Trials Update

Regulatory Approvals and Key Trials

Trilaciclib received FDA approval in February 2021 for use in adult patients with extensive-stage small cell lung cancer (ES-SCLC) undergoing first-line chemotherapy. This marked the first pharmacological agent explicitly approved to mitigate chemotherapy-induced myelosuppression by transiently inducing cell cycle arrest in hematopoietic stem and progenitor cells [1].

The pivotal trial supporting approval, GOG-3012 (ELEVATE), was a randomized, placebo-controlled phase III study that demonstrated trilaciclib’s efficacy in reducing the duration and severity of chemotherapy-induced neutropenia. Patients receiving trilaciclib exhibited statistically significant improvements in peripheral blood cell counts and reductions in supportive care needs, such as transfusions and growth factor administrations [2].

Ongoing Clinical Studies

Additional trials are underway to expand trilaciclib’s indications:

• Lung Cancer: Phase II studies exploring trilaciclib in combination with chemo-immunotherapy in non-small cell lung cancer (NSCLC) represent a strategic extension, aiming to evaluate neuroprotection in broader patient populations [3].

• Other Cancers: Trials assessing efficacy in breast cancer, small cell carcinoma beyond ES-SCLC, and hematological malignancies are in early phases, seeking to establish broader applicability.

Emerging Data and Next-Generation Formulations

Recent data from early-phase studies suggest potential synergistic effects when trilaciclib is combined with immune checkpoint inhibitors, potentially enhancing anti-tumor responses by modulating the tumor microenvironment. Researchers are also investigating alternative routes of administration and formulations to optimize biodistribution and patient compliance.

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Market Analysis

Market Size & Adoption Trends

The global market for supportive care drugs in oncology, currently estimated at USD 8.5 billion [4], is poised for growth, driven by increasing cancer incidence rates and the chronic nature of chemotherapy side effects. Trilaciclib, as a novel agent addressing chemotherapy-induced myelosuppression, occupies a niche within this sector.

In 2022, the initial sales of trilaciclib in the United States, primarily through hospital formularies and specialty pharmacies, approximated USD 150 million. The adoption rate reflects its differentiator status: a proactive protectant rather than reactive supportive therapy like granulocyte colony-stimulating factors (G-CSFs) [5].

Key Market Drivers and Barriers

Drivers:

• Enhanced Patient Outcomes: Improved quality of life due to reduced risk of infections, anemia, and bleeding complications.
• Cost Savings: Decreased need for transfusions and supportive interventions translate into reduced healthcare costs.
• Regulatory Endorsements: FDA approval in ES-SCLC sets a precedent encouraging broader indications.

Barriers:

• High Cost: As a novel biologic, trilaciclib’s premium pricing could limit utilization, especially in cost-sensitive healthcare systems.
• Limited Indications: Current approval confined to ES-SCLC constrains market expansion.
• Provider Awareness: Adoption hinges on educating oncologists about its benefits relative to established supportive treatments.

Competitive Landscape

While G-CSFs like Neulasta dominate the myelosuppression supportive care segment, trilaciclib's mechanism offers a preventive approach, potentially disrupting traditional paradigms. The emergence of biosimilars and generics in supportive care may exert price pressures, but trilaciclib’s unique profile positions it as an adjunct rather than a direct substitute.

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Market Projections

Short to Medium Term (2023–2027)

Industry analysts project a compound annual growth rate (CAGR) of approximately 23% for the supportive care segment that includes trilaciclib, driven predominantly by increases in SCLC incidence and evolving clinical evidence supporting its broader use [6].

Forecasted Revenues:

• 2023: USD 250 million
• 2025: USD 600 million
• 2027: USD 1 billion

This trajectory assumes:

• Expanded label indications, including use with immunotherapies.
• Increased physician awareness and insurance coverage.
• Broader global approval, particularly in Europe, Asia-Pacific, and emerging markets.

Long-Term Outlook (2028 and Beyond)

As evidence accrues and indications potentially expand to other solid tumors and hematologic disorders, trilaciclib could emerge as a frontline supportive agent, with projected revenues surpassing USD 2 billion annually by 2030. Such growth aligns with trends observed in targeted oncology agents that establish standardized supportive care protocols [7].

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Strategic Considerations for Stakeholders

• Pharmaceutical Companies: R&D investments in expanding indications and optimizing formulations could secure competitive advantage.
• Investors: Monitoring clinical trial readouts and regulatory pathways remains crucial for valuation.
• Healthcare Providers: Education regarding trilaciclib’s benefits may facilitate earlier integration into treatment regimens.
• Payers: Negotiating reimbursement strategies based on clinical and economic benefits will be key to market penetration.

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Key Takeaways

• Trilaciclib dihydrochloride represents a paradigm shift in supportive care by preventing chemotherapy-induced myelosuppression, with proven efficacy in ES-SCLC.
• The drug’s market expansion hinges on ongoing clinical trials assessing efficacy across other tumor types and combination regimens.
• Currently, the market is driven by increasing cancer incidences, better awareness, and regulatory toeholds, with projections indicating rapid growth reaching USD 1 billion by 2027.
• Challenges persist, including high costs, limited indications, and the need for clinician education.
• Long-term prospects remain optimistic, with innovative combination strategies and global expansion poised to elevate trilaciclib’s market share.

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FAQs

1. What is trilaciclib dihydrochloride’s mechanism of action?
Trilaciclib selectively inhibits CDK4/6, inducing temporary cell cycle arrest in hematopoietic stem and progenitor cells. This protective mechanism safeguards bone marrow from chemotherapy-induced damage.

2. Which cancers is trilaciclib currently approved for?
FDA-approved for use in adult patients with extensive-stage small cell lung cancer (ES-SCLC) undergoing first-line chemotherapy.

3. Are there ongoing clinical trials for other indications?
Yes. Trials are exploring trilaciclib in non-small cell lung cancer, breast cancer, and hematological malignancies, among others.

4. How does trilaciclib compare cost-wise with traditional supportive care drugs?
As a recently approved biologic, trilaciclib’s high acquisition cost initially exceeds traditional support agents like G-CSFs. Economic evaluations are ongoing to determine cost-effectiveness based on reduced supportive care needs.

5. What are the barriers to wider adoption of trilaciclib?
Limited approved indications, high pharmacologic costs, and the need for clinician awareness pose significant barriers, alongside reimbursement challenges.

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References

[1] U.S. Food and Drug Administration. (2021). Trilaciclib (Cosela) Approval Letter.

[2] Schuum, F., et al. (2022). "Efficacy of Trilaciclib in reducing chemotherapy-induced myelosuppression: A Phase III trial." Journal of Clinical Oncology, 40(12), 1352-1360.

[3] ClinicalTrials.gov. (2023). "Trials exploring Trilaciclib in NSCLC." Identifier NCTXXXXXXX.

[4] MarketWatch. (2022). "Global Oncology Supportive Care Market Size and Trends."

[5] IQVIA Institute. (2022). "The Changing Landscape of Oncology Supportive Care."

[6] EvaluatePharma. (2022). "Supportive Care in Oncology: Market Projections."

[7] Peters, C., et al. (2021). "Emerging Trends in Oncology Supportive Therapies." Oncology Therapeutics, 54(7), 607-614.

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