CLINICAL TRIALS PROFILE FOR NEXAVAR

505(b)(2) Clinical Trials for NEXAVAR

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT02636426 ↗	Sorafenib Administered Using a High-dose, Pulsatile Regimen: a Phase I Exposure Escalation Study	Completed	VU University Medical Center	Phase 1	2015-09-01	Sorafenib is an oral anticancer drug and inhibits multiple protein kinases important for tumor growth and metastases, including VEGFR, PDGFR, and RAF kinases. In daily clinical practice it is currently used at a dose of 400 mg twice daily in a continuous schedule. In this phase I study patients will be treated with a new dosing schedule of sorafenib: i.e. a high-dose, pulsatile schedule. The tolerability and safety of this new schedule is examined in exposure escalation cohorts based on a target plasma AUC0-12h (area under the curve). Exposure escalation cohorts are used instead of conventional dose escalation cohorts because the effect of a drug is dependent of its AUC levels and large differences in plasma sorafenib AUC0-12h have previously been shown between patients treated at the same dose level. Using pharmacokinetic monitoring, the sorafenib dose will be adjusted to a target plasma AUC0-12h. The escalation cohorts consist of 3-6 patients per exposure level starting with a target plasma sorafenib AUC0-12h level of 25-50 mg/L/h. After the determination of the maximum tolerated AUC0-12h, 10 additional patients will be entered into an expansion cohort. In the expansion cohort the patients will be treated with a weekly pulse of sorafenib at the maximum tolerated AUC0-12h for further assessment of safety and preliminary exploration of efficacy.

All Clinical Trials for NEXAVAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00064350 ↗	Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2004-05-01	RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib. PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.
NCT00064350 ↗	Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer	Completed	Eastern Cooperative Oncology Group	Phase 2	2004-05-01	RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib. PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.
NCT00079612 ↗	Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer	Completed	Amgen	Phase 2	2002-09-01	The purpose of the study is to: - Find out if BAY 43-9006 prevents the growth of tumors - For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time. - Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers. - Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.
NCT00079612 ↗	Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer	Completed	Onyx Pharmaceuticals	Phase 2	2002-09-01	The purpose of the study is to: - Find out if BAY 43-9006 prevents the growth of tumors - For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time. - Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers. - Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.
NCT00079612 ↗	Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer	Completed	Bayer	Phase 2	2002-09-01	The purpose of the study is to: - Find out if BAY 43-9006 prevents the growth of tumors - For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time. - Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers. - Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.
NCT00093613 ↗	Sorafenib in Treating Patients With Recurrent or Progressive Malignant Glioma	Completed	National Cancer Institute (NCI)	Phase 1	2004-12-01	This phase I trial is studying the side effects and best dose of sorafenib in treating patients with recurrent or progressive malignant glioma. Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth.
NCT00093626 ↗	Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer	Completed	Gynecologic Oncology Group	Phase 2	2004-10-01	Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. This phase II trial is studying how well sorafenib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.

Clinical Trial Conditions for NEXAVAR

Condition Name

Condition Name for NEXAVAR
Intervention	Trials
Hepatocellular Carcinoma	38
Carcinoma, Renal Cell	18
Carcinoma, Hepatocellular	16
Liver Cancer	14

Condition MeSH

Condition MeSH for NEXAVAR
Intervention	Trials
Carcinoma	121
Carcinoma, Hepatocellular	91
Carcinoma, Renal Cell	43
Liver Neoplasms	31

Clinical Trial Locations for NEXAVAR

Trials by Country

Trials by Country for NEXAVAR
Location	Trials
Germany	54
China	53
Canada	51
Japan	45
France	34

Trials by US State

Trials by US State for NEXAVAR
Location	Trials
Texas	57
California	50
Pennsylvania	47
New York	45
Florida	43

Clinical Trial Progress for NEXAVAR

Clinical Trial Phase

Clinical Trial Phase for NEXAVAR
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	21
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for NEXAVAR
Clinical Trial Phase	Trials
Completed	187
Terminated	53
Active, not recruiting	22

Clinical Trial Sponsors for NEXAVAR

Sponsor Name

Sponsor Name for NEXAVAR
Sponsor	Trials
National Cancer Institute (NCI)	104
Bayer	89
M.D. Anderson Cancer Center	16

Sponsor Type

Sponsor Type for NEXAVAR
Sponsor	Trials
Other	254
Industry	186
NIH	105

Last updated: April 27, 2026

Nexavar (sorafenib): Clinical-trial status, market analysis, and projections

What is Nexavar and what is its current clinical-trial footprint?

Nexavar is the brand name for sorafenib (multi-kinase inhibitor). While sorafenib’s pivotal efficacy dates to earlier development, the current clinical-trials footprint remains dominated by (1) additional indications and (2) trial follow-on work in oncology, often in combination regimens.

Current trial activity (registry-based snapshot) A registry pull on public clinical-trial databases typically shows a mix of completed and terminated studies across solid tumors, with fewer active interventional trials than during peak development years. The majority of current activity is not powered to recreate initial approvals but to refine patient selection, combination strategies, and biomarker-defined cohorts. (No active interventional lifecycle details are enumerated here because a complete, accurate, date-stamped status list cannot be produced without a live registry extract.)

What matters for decision-making

• Sorafenib’s development strategy has shifted from first-line registrational work to narrower combination and biomarker-context studies in oncology settings.
• The practical R&D value today is less about new monotherapy breakthroughs and more about where sorafenib still has clinical utility versus newer kinase inhibitors and immuno-oncology regimens.

What approvals and label-relevant clinical endpoints shape the market?

Nexavar’s market position is anchored to established regulatory labels in oncology (notably liver and kidney indications historically tied to sorafenib’s evidence base) and the long tail of real-world use. In most geographies, sorafenib competes against newer standards such as VEGF pathway inhibitors, immune checkpoint inhibitors, and combination regimens that have displaced monotherapy in several disease settings.

How label history translates into economics

• Label duration drives residual demand, especially where clinicians and payers still have established prescribing patterns.
• Combination positioning matters: even when sorafenib is not first-line in many settings, it can retain constrained use in specific lines of therapy depending on local guidelines and reimbursement.

What is the Nexavar market landscape and competitive set?

Sorafenib’s market is a mature oncology drug market with sustained but generally pressured demand from next-generation therapies. Competitive pressure is multi-axis:

• Direct competitors: other VEGFR and multi-kinase inhibitors used across RCC and HCC.
• Indirect displacement: immune checkpoint inhibitor based first-line therapy and newer combinations that reduce monotherapy utilization.

Competitive substitution dynamics

• In RCC, sequential use patterns favor newer TKIs and IO/TKI combinations that improve outcomes relative to older benchmarks.
• In HCC, first-line systemic standards have moved toward immunotherapy-based regimens in many markets, compressing remaining monotherapy shares.

How is the market projected to evolve under current oncology standards?

A realistic projection for Nexavar depends on (1) line-of-therapy displacement by newer agents, (2) patient access and payer restrictions, and (3) geographic variation in guideline adoption. Without up-to-date sales telemetry and without a live payer and guideline map by geography, a single-point numeric forecast cannot be produced in a way that meets the “complete and accurate response” requirement.

Projection logic (directional)

• Baseline trajectory: declining or plateauing unit demand in major markets due to displacement by newer systemic regimens.
• Offset factors: residual use in patients who cannot tolerate or are ineligible for alternatives; ongoing combination utility in select settings; inventory, contracting, and tender dynamics.
• Net effect: modest residual growth is unlikely absent a new registrational indication or major guideline reinstatement of sorafenib monotherapy or specific combinations.

What patent and exclusivity constraints define commercial runway?

Sorafenib is an older small-molecule oncology drug; as a result, Nexavar is long outside primary exclusivity in most markets. Commercial outcomes are therefore driven by:

• Generic substitution rates (and the timing of generic entry in each country).
• Line-of-therapy positioning versus newer branded or protected molecules.
• Formulation and lifecycle events (if any) that can extend market access in certain jurisdictions.

A precise exclusivity/patent runway by country cannot be enumerated accurately here without a jurisdiction-by-jurisdiction legal status set.

What are key data sources and how to interpret them for a live update?

For a clinical and market update that can support investment or R&D planning, the work is typically split into three deliverables:

1. Clinical trials registry audit: count of studies by status (active, recruiting, completed, terminated), by indication, and by sponsor.
2. Label and guideline mapping: where sorafenib still fits in treatment sequencing and line-of-therapy.
3. Market model build: base demand from historical sales or prescriptions, then apply penetration rates for competing standards, generic pricing curves, and payer restrictions.

In this prompt, the request requires a complete and accurate clinical-trial status and market projection. A complete list of active/recruiting trials and a numeric market forecast cannot be produced without a live registry and current sales dataset extract.

Key Takeaways

• Nexavar (sorafenib) remains a mature oncology asset with clinical-trial activity that is mostly post-approval follow-on rather than registrational innovation.
• Market demand is structurally pressured by displacement in RCC and HCC treatment standards from newer IO and TKI regimens.
• The practical outlook is a plateau-to-decline pattern driven by generic substitution and line-of-therapy shifts rather than a rebound from new evidence.
• Any numeric market projection or active-trial count requires a live clinical registry and current sales inputs to be complete and accurate.

FAQs

1) Is Nexavar still under active clinical investigation?
Yes, but most activity is post-approval research (combinations, patient selection, and context studies) rather than new core registrational pivots.

2) What disease areas drive sorafenib demand today?
Historically RCC and HCC, with current utilization shaped by evolving first-line systemic standards and local guideline adoption.

3) How does generic competition affect Nexavar’s market outlook?
Generic entry typically compresses branded revenue and drives demand to lower-priced equivalents, flattening or reducing branded-market share.

4) What most strongly determines market projection direction for sorafenib?
Treatment sequencing in oncology guidelines, payer restrictions, and the speed at which newer IO/TKI regimens displace older TKI monotherapy.

5) What would change the outlook materially?
A new registrational indication with meaningful survival benefit, or major guideline reinstatement of a sorafenib-based regimen as standard of care in a large patient segment.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] European Medicines Agency. Nexavar: EPAR product information (sorafenib). https://www.ema.europa.eu/