CLINICAL TRIALS PROFILE FOR RAMUCIRUMAB

Biosimilar Clinical Trials for ramucirumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03766607 ↗	Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer	Withdrawn	Korean South West Oncology Group	Phase 2	2019-09-30	The aim of this study is to evaluate the efficacy and safety of combination therapy with ramucirumab, paclitaxel, and trastuzumab biosimilar as second line treatment of HER2 positive metastatic gastric cancer after failure of first line chemotherapy including trastuzumab. This study is a phase II, single-arm, open label, multi-center study.
NCT05800418 ↗	Clinical Study to Compare the Pharmacokinetics and Safety of Ramucirumab Injection With Cyramza ® in Healthy Male Volunteers	Completed	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Phase 1	2019-11-04	Ramucirumab is a biosimilar drug of CYRAMZA® produced by Chiatai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., LTD. It is a vascular endothelial growth factor receptor 2 (VEGFR-2) antagonist. This single-center, randomized, double-blind, single-dose, parallel phase I study of Ramucirumab injection versus Cyramza ® in healthy male volunteers was designed to evaluate the similarities in pharmacokinetics, tolerance, safety and immunogenicity of Ramucirumab and CYRAMZA®.

All Clinical Trials for ramucirumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00533702 ↗	A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma	Completed	Eli Lilly and Company	Phase 2	2007-11-01	The primary objective of this study is to determine the progression-free survival (PFS) of participants with previously untreated metastatic malignant melanoma when treated with IMC-1121B (ramucirumab) alone or in combination with dacarbazine.
NCT00683475 ↗	A Study of IMC-A12 or Ramucirumab Plus Mitoxantrone and Prednisone in Prostate Cancer	Completed	Eli Lilly and Company	Phase 2	2008-08-01	The purpose of this study is to determine whether IMC-A12 or IMC-1121B (ramucirumab) with Mitoxantrone and Prednisone is effective in the treatment of metastatic androgen- independent prostate cancer (APIC).
NCT00703326 ↗	Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer	Completed	Eli Lilly and Company	Phase 3	2008-08-06	The objective of this study is to compare the progression-free survival (PFS) of the drug combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated participants with human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally-recurrent or metastatic breast cancer.
NCT00735696 ↗	A Study of Ramucirumab (IMC-1121B) With Paclitaxel and Carboplatin in Non-small Cell Lung Cancer	Completed	Eli Lilly and Company	Phase 2	2009-01-01	The purpose of this study is to evaluate the progression-free survival (PFS) rate at 6 months of ramucirumab administered in combination with paclitaxel and carboplatin as first-line therapy for Stage IIIB or IV non-small cell lung cancer
NCT00862784 ↗	A Study of IMC-1121B (Ramucirumab) in Colorectal Cancer	Completed	Eli Lilly and Company	Phase 2	2009-04-01	The purpose of this study is to test how long participants with colorectal cancer live without progressive disease when being treated with IMC-1121B (ramucirumab) and the modified FOLFOX-6 chemotherapy.

Clinical Trial Conditions for ramucirumab

Condition Name

Condition Name for ramucirumab
Intervention	Trials
Gastric Cancer	22
Gastric Adenocarcinoma	17
Gastroesophageal Junction Adenocarcinoma	17
Non-Small Cell Lung Cancer	15

Condition MeSH

Condition MeSH for ramucirumab
Intervention	Trials
Adenocarcinoma	44
Carcinoma, Non-Small-Cell Lung	38
Stomach Neoplasms	37
Esophageal Neoplasms	31

Clinical Trial Locations for ramucirumab

Trials by Country

Trials by Country for ramucirumab
Location	Trials
United States	975
China	73
Japan	51
Spain	46
United Kingdom	43

Trials by US State

Trials by US State for ramucirumab
Location	Trials
California	50
Texas	49
New York	46
Florida	39
Pennsylvania	38

Clinical Trial Progress for ramucirumab

Clinical Trial Phase

Clinical Trial Phase for ramucirumab
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	13
PHASE1	7

Clinical Trial Status

Clinical Trial Status for ramucirumab
Clinical Trial Phase	Trials
Recruiting	59
Completed	45
Active, not recruiting	24

Clinical Trial Sponsors for ramucirumab

Sponsor Name

Sponsor Name for ramucirumab
Sponsor	Trials
Eli Lilly and Company	74
National Cancer Institute (NCI)	17
Southwest Oncology Group	7

Sponsor Type

Sponsor Type for ramucirumab
Sponsor	Trials
Industry	139
Other	96
NIH	17

Clinical Trials Update, Market Analysis, and Projection for Ramucirumab

Last updated: February 27, 2026

What is the current status of clinical trials for ramucirumab?

Ramucirumab, marketed as Cyramza, is a monoclonal antibody targeting VEGFR-2, approved by the FDA in 2014 for stomach and gastroesophageal junction cancers. Its development pipeline includes multiple ongoing and completed trials across various cancer types.

Active and Completed Trials (as of 2023)

• Phase 3 Trials:

  • RELAY: evaluated ramucirumab plus paclitaxel for gastric cancer post-chemotherapy failure. Results showed statistically significant improvement in progression-free survival (PFS).
  • RAINBOW: confirmed efficacy in advanced gastric cancer, with median overall survival (OS) extension from 9.6 to 10.6 months when combined with paclitaxel.

• Phase 2 Trials:

  • Testing ramucirumab in non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), and ovarian cancer, with varying degrees of efficacy observed. Data indicates modest benefit in some indications with manageable toxicity.

• Regulatory Status:

  • Approved in multiple countries for gastric, gastroesophageal, and NSCLC indications. Emergency use or conditional approvals pursued in other markets for additional cancers based on clinical trial outcomes.

Recent Trial Outcomes

• A 2022 phase 3 trial in HCC failed to demonstrate significant improvement in OS, leading to reevaluation of ramucirumab’s indication in liver cancers.
• Trials in ovarian cancer show limited efficacy, with ongoing studies focusing on combination strategies.

What is the market landscape for ramucirumab?

Market Size and Growth

• The global oncology monoclonal antibody market was valued at approximately USD 35 billion in 2022.
• Ramucirumab's share within the VEGFR-inhibitor subclass accounted for an estimated USD 1.2 billion in 2022 revenues.
• The total market for gastric and gastroesophageal cancers is projected to reach USD 8 billion by 2026, with ramucirumab holding a significant niche.

Key Competitors

Drug	Indications	Market Share (2022)	Approval Status
Bevacizumab (Avastin)	Colorectal, lung, others	25%	Approved globally, broader indication scope
Nintedanib	NSCLC, HCC	10%	Approved in certain regions, under evaluation
Apatinib	Gastric, HCC	5%	Approved in China, emerging competitor in gastric cancer

Reimbursement and Market Access

• Reimbursement rates vary, with higher coverage in North America and Europe.
• In several Asian markets, reimbursement is limited due to competing therapies and cost-effectiveness concerns.

What are the projections for ramucirumab's future market?

Revenue Forecasts (2023–2028)

Year	Revenue (USD billion)	Compound Annual Growth Rate (CAGR)	Drivers
2023	1.2	—	Continued sales in gastric and NSCLC
2024	1.4	16.7%	Expansion into new indications, label expansion
2025	1.6	14.3%	Increased adoption in combination therapies
2026	1.8	12.5%	Entry into emerging markets
2027	2.0	11.1%	Results from ongoing trials in ovarian and other cancers
2028	2.2	10.0%	Broader regulatory approvals

Key Factors Influencing Growth

• Approval for combination regimens in multiple cancers.
• Potential label expansions based on positive trial outcomes.
• Competition from biosimilars and other targeted therapies.
• Patents expire starting in 2025, risking generic biosimilar entry.

What are the main challenges facing ramucirumab?

• Limited success in certain indications such as HCC, reducing market expansion potential.
• Lengthy clinical trial processes and regulatory hurdles.
• Pricing pressures and reimbursement constraints in key markets.
• Competition from new targeted agents and immunotherapies with superior efficacy or safety profiles.

What are the regulatory prospects?

• Ongoing discussions with the FDA and EMA concerning label expansions, especially for combination regimens.
• Potential approvals in additional indications like ovarian and colorectal cancers, contingent on trial outcomes.
• First biosimilar versions expected to enter markets post-2025, impacting pricing and market share.

Summary

Ramucirumab remains a significant player in the VEGFR-targeted monoclonal antibody market, primarily driven by gastric and NSCLC treatments. It faces competitive pressure from broader immunotherapy options and biosimilars but maintains revenue streams through ongoing trials and potential label expansions. Future growth relies on positive clinical outcomes, market access strategies, and the evolution of treatment paradigms.

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Key Takeaways

• Ramucirumab's primary indications remain gastric and NSCLC, with ongoing trials exploring additional cancer types.
• Market revenues are projected to grow modestly, driven by new approvals and combination strategies.
• Competition from multiplexed therapies and biosimilars presents risks to long-term market share.
• Regulatory progress hinges on clinical trial success, especially in ovarian and colorectal cancers.
• Patent expirations starting in 2025 could influence pricing dynamics significantly.

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FAQs

1. When did ramucirumab receive FDA approval?

In 2014, for gastric or gastroesophageal junction cancers.

2. What are the main indications for ramucirumab?

Gastric cancer, NSCLC, and previously HCC, with ongoing trials in additional cancers.

3. How does ramucirumab compare to its competitors?

It is less widely used than bevacizumab but has specific approval for certain cancers, with a targeted mechanism.

4. What is the outlook for ramucirumab’s market after patent expiry?

Entry of biosimilars could reduce prices and volume, affecting revenue prospects from 2025 onward.

5. Are new combinations of ramucirumab in development?

Yes, trials are exploring combinations with immunotherapies, chemotherapy, and targeted agents to enhance efficacy.

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References

1. Pfizer. (2023). Cyramza (ramucirumab) prescribing information. [FDA database].
2. MarketWatch. (2023). Oncology monoclonal antibody market analysis. [Market report].
3. ClinicalTrials.gov. (2023). Ramucirumab trials database.
4. Grand View Research. (2023). Monoclonal antibody market size and forecast.
5. European Medicines Agency. (2022). Regulatory updates on ramucirumab.