CLINICAL TRIALS PROFILE FOR NAVELBINE

505(b)(2) Clinical Trials for NAVELBINE

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 Combination	NCT01884428 ↗	Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma	Unknown status	Armando Santoro, MD	Phase 1	2011-07-01	study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose
New Combination	NCT02897986 ↗	Study of a Propranolol (HEMANGIOL®) and Oral Metronomic Vinorelbine (NAVELBINE®) Combination for Children and Teenagers With Refractory/Relapsing Solid Tumors	Unknown status	Assistance Publique Hopitaux De Marseille	Phase 1	2017-01-01	Cancer remains the first cause of death due to disease in children and adolescents despite important progress and 70% of the survivors present sequelae. It is therefore mandatory to generate new and preferably less toxic treatment strategies relying on new anticancer agents, and/or new combinations or schedules of administered compounds. Metronomic chemotherapy (MC) consists in administrating low doses of anticancer agents on a daily/weekly basis. MC has been showed to be a safe and effective way to administer chemotherapy to obtain anti-cancer effects through anti-angiogenic and pro-imune effects. Drug repositioning consist in using non-anticancer drug for which anti-cancer properties have been unveiled. Propranolol is a non selective beta-blocker initially used to treat hypertension but recently its anticancer properties have been discovered. The place of Betablockers as anticancer agents is supported by both preclinical and epidemiologic data. The investigators have showed that the use of betablockers could sensitize breast cancer, angiosarcoma and neuroblastoma to chemotherapy in vitro and in vivo at least in part via an anti-angiogenic mechanism. There are currently 12 clinical trials evaluating prospectively their potential in adults with cancer but none in children so far. The Objective is to determine the Maximal Tolerated Dose (MTD) of a combination of oral metronomic vinorelbine and daily oral propranolol. This study is a phase I trial with a "rolling six" design and a dose escalation with thrice weekly oral vinorelbine only plus addition of daily oral propranolol after completion of the first cycle. PK analysis of vinorelbine and propranolol will be performed. Once the recommended dose of the combination established 4 extension cohorts of 9 patients will be added Potential biomarkers (such as beta-adrenergic receptors on the tumours, B-tubulin isotypes in the tumour) will also be evaluated. This will provide a well tolerated, all oral combination for patients with refractory/relapsing tumours. This combination could also be then proposed as a maintenance for instance in patients with rhabdomyosarcoma or neuroblastoma.

All Clinical Trials for NAVELBINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002813 ↗	Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1997-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cisplatin and vinorelbine in treating patients with refractory or recurrent squamous cell cervical cancer that has not responded to local therapy.
NCT00002813 ↗	Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer	Completed	Gynecologic Oncology Group	Phase 2	1997-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cisplatin and vinorelbine in treating patients with refractory or recurrent squamous cell cervical cancer that has not responded to local therapy.
NCT00003234 ↗	Vinorelbine in Treating Children With Recurrent or Refractory Cancers	Completed	National Cancer Institute (NCI)	Phase 2	1998-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer.
NCT00003234 ↗	Vinorelbine in Treating Children With Recurrent or Refractory Cancers	Completed	Children's Oncology Group	Phase 2	1998-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer.
NCT00003587 ↗	S9806: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1998-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer
NCT00003587 ↗	S9806: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer	Completed	Southwest Oncology Group	Phase 2	1998-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer

Clinical Trial Conditions for NAVELBINE

Condition Name

Condition Name for NAVELBINE
Intervention	Trials
Breast Cancer	34
Non-small Cell Lung Cancer	10
Metastatic Breast Cancer	10
Non Small Cell Lung Cancer	9

Condition MeSH

Condition MeSH for NAVELBINE
Intervention	Trials
Breast Neoplasms	54
Carcinoma, Non-Small-Cell Lung	41
Lung Neoplasms	38
Lymphoma	11

Clinical Trial Locations for NAVELBINE

Trials by Country

Trials by Country for NAVELBINE
Location	Trials
United States	509
Canada	46
Italy	46
Spain	31
France	17

Trials by US State

Trials by US State for NAVELBINE
Location	Trials
Illinois	24
California	23
Florida	20
Washington	19
Massachusetts	19

Clinical Trial Progress for NAVELBINE

Clinical Trial Phase

Clinical Trial Phase for NAVELBINE
Clinical Trial Phase	Trials
Phase 3	25
Phase 2/Phase 3	2
Phase 2	80

Clinical Trial Status

Clinical Trial Status for NAVELBINE
Clinical Trial Phase	Trials
Completed	68
Terminated	23
Unknown status	16

Clinical Trial Sponsors for NAVELBINE

Sponsor Name

Sponsor Name for NAVELBINE
Sponsor	Trials
National Cancer Institute (NCI)	24
University Hospital of Crete	9
Hellenic Oncology Research Group	8

Sponsor Type

Sponsor Type for NAVELBINE
Sponsor	Trials
Other	193
Industry	62
NIH	26

Navelbine (vinorelbine) Clinical Trials Update, Market Analysis and Patent/Generic Risk Outlook

Last updated: May 24, 2026

Navelbine (vinorelbine) is an established, off-patent oncology product with multiple legacy formulations and method-of-use protections historically tied to the chemotherapy standard of care in non-small cell lung cancer (NSCLC) and advanced breast cancer. Current “clinical trials updates” for vinorelbine concentrate on new combinations, translational biomarker studies, and regimen optimization rather than de novo pivotal drug-development programs. Commercially, Navelbine’s market is mature and tied to generic availability, tender dynamics, and regional reimbursement, with incremental growth driven by guideline positioning and substitution controls for specific dosage forms.

What is Navelbine (vinorelbine) used for and where does it sit in current NSCLC and breast cancer treatment?

Navelbine (vinorelbine) is a vinca alkaloid used in oncology, most commonly in:

• NSCLC
  • First-line combination chemotherapy in selected patients and settings historically aligned with vinorelbine-containing regimens.
• Advanced breast cancer
  • Commonly used in combination chemotherapy in advanced disease, historically including regimens with anthracyclines and taxanes or as a component of sequential therapy.

Where it fits today (practical positioning)

• In many jurisdictions, vinorelbine remains a chemotherapy option rather than a targeted therapy.
• Its role is constrained by the presence and growth of other chemotherapy classes and, in subsets, targeted and immune-oncology options. That said, vinorelbine remains included in chemo pathways where cytotoxics are used.

Key dosage forms

• Oral capsules (vinorelbine tartrate, product historically marketed as Navelbine and related brand lines depending on country)
• Injection (IV) Brand naming and labeling vary by territory, but the active ingredient is vinorelbine.

What is the current clinical trials landscape for vinorelbine (Navelbine)?

Vinorelbine clinical activity in recent years is dominated by:

• Combination trials in NSCLC and breast cancer
• Dose and schedule optimization
• Translational studies assessing biomarkers linked to response and toxicity (eg, pharmacogenomic and predictive markers)
• Real-world evidence and retrospective outcomes supporting regimen use

What to expect from current “trial updates” Given Navelbine’s established status, most new studies do not redefine vinorelbine’s core pharmacology. They refine:

• sequencing with other chemo agents
• pairing with targeted therapies or immunotherapies (where relevant and based on study hypotheses)
• management of adverse events and dosing feasibility

Which companies are running the newest vinorelbine combination trials?

The vinorelbine trial ecosystem is typically global and multi-institution, with sponsors often including:

• academic groups running investigator-initiated combination studies
• oncology pharma companies testing backbone chemotherapy combinations
• regional cooperatives coordinating multi-country trials

A consistent pattern across older and new vinorelbine studies is that vinorelbine is used as a chemotherapy backbone rather than the investigational “primary mechanism.”

Are there any recent pivotal phase 3 results for Navelbine (vinorelbine)?

Vinorelbine’s recent public trial activity is largely non-pivotal relative to the original regulatory milestones. Contemporary programs tend to support:

• regimen changes
• combination feasibility and efficacy signals
• subgroup analyses and safety profiling

If a pivotal phase 3 had materially changed standard-of-care or regulatory status in major markets recently, it would typically be reflected in updated labeling and widespread treatment guideline adoption. Current market conditions suggest no such “new label expansion” driver has displaced the generic and commoditization timeline.

How does vinorelbine’s safety and administration profile affect trial design and adoption?

Common practical considerations in vinorelbine studies and routine use include:

• Neurotoxicity and myelosuppression
• Dose modifications and supportive care requirements
• Schedule-dependent tolerability, especially in combination regimens

These factors shape endpoints such as:

• progression-free survival (PFS) in NSCLC
• response rate, duration of response (DoR), and tolerability endpoints in breast cancer
• treatment discontinuation due to adverse events

What is Navelbine’s market size and revenue exposure by geography?

Navelbine is a mature product where:

• pricing pressure from generics reduces revenue opportunities
• tender procurement in hospital systems drives volume shares
• brand survival depends on country-level substitution controls and supply reliability

Typical commercial pattern for mature IV/oral cytotoxics

• IV formulations often retain share due to hospital procurement preferences and substitution frictions.
• Oral formulations face stronger substitution dynamics once generics are fully available.

Because vinorelbine is long-established and widely genericized in most major markets, revenue is usually concentrated in:

• regions with slower tender substitution cycles
• markets where specific formulations remain under brand-protected positioning (where applicable)
• stable indications with entrenched clinician familiarity

What market growth is realistic for vinorelbine versus other NSCLC and breast cancer chemo backbones?

Realistic growth assumptions in a mature chemotherapy:

• are usually low single-digit to flat in the absence of labeling expansion
• can show temporary uplifts tied to guideline cycles or stock/availability issues
• depend on country-specific reimbursement and hospital formularies

Any sustained growth beyond flat-to-low-single-digit typically requires one of:

• measurable efficacy superiority in a defined regimen niche
• a formulation or access advantage that delays substitution
• a new regulatory milestone (rare for legacy vinorelbine)

What are the major drivers of demand for vinorelbine (Navelbine)?

Demand is supported by:

• entrenched chemotherapy use in NSCLC and advanced breast cancer
• physician preference in specific regimen constructs
• compatibility with combination regimens (as a backbone)
• continuity in hospital formularies, where chemotherapy backbone preferences persist

How many patents protect Navelbine (vinorelbine), and what is the estate strength by use, formulation, and manufacturing?

For vinorelbine, the original chemical composition is long expired. Remaining protection historically falls into:

• formulation patents (capsule and injection formulation refinements)
• method-of-use patents tied to regimen constructs (less common for widely generic products now)
• manufacturing process patents (often expired or weakened by generic design-around)

In a mature commodity, the patent estate strength typically declines sharply after:

• first-wave formulation expirations
• clearance of major method-of-use claims
• market entry settlement histories

When does Navelbine lose exclusivity in key markets (US, EU, UK)?

Vinorelbine is generally treated as off-exclusivity in major markets based on historical launch timelines and broad generic availability. Exclusivity timing is usually anchored to:

• the earliest composition or key intermediate patents (now expired)
• later formulation and process patents (mostly expired or no longer market-relevant)

Practical takeaway: exclusivity is not the primary determinant of current access. Generic competition and tender dynamics are.

What is the Orange Book status of Navelbine (vinorelbine) in the US?

In the US, Orange Book listings for older cytotoxics typically show:

• limited remaining listed patents, if any, tied to legacy brand products
• multiple generic ANDAs with approvals contingent on patent carve-outs (Paragraph IV where applicable historically)

For a mature product, the Orange Book status is usually dominated by generic entries rather than active brand-only exclusivity.

What Paragraph IV challenges exist for vinorelbine (Navelbine) and how did settlements affect market entry?

Paragraph IV challenges historically occurred when generics sought approval during the tail of remaining brand-listed patents. For vinorelbine, with widespread availability now, the remaining impact is mainly:

• established generic-to-brand market share outcomes
• procurement and pricing behaviors that persist even after patent clearance

The current market condition implies that any most consequential settlements already occurred earlier in the product lifecycle.

What patent litigation affects Navelbine (vinorelbine) today?

For mature products, present-day litigation is usually limited to:

• post-launch infringement disputes involving specific formulation or packaging claims (rare at scale once products are entrenched and generic competition is stable)
• limited residual fights around process changes

In practice, the ongoing commercial reality indicates that litigation is not a primary bottleneck to access in major markets today.

What generic entry risks exist for Navelbine (vinorelbine) in markets where substitution is delayed?

Where substitution is delayed, risks are driven by:

• supply chain reliability of approved generic manufacturers
• pharmacy and hospital contracting constraints
• local regulatory processes affecting bioequivalence acceptance and substitution policies

IP is generally not the gating factor at this stage; access barriers are procurement and regulatory operational constraints.

How does vinorelbine compare with competing NSCLC chemotherapy regimens in market attractiveness?

Vinorelbine competes within multi-agent chemotherapy ecosystems against:

• taxanes (docetaxel, paclitaxel)
• anthracyclines
• other vinca alkaloids and chemo backbones depending on regimen
• platinum-based combinations and newer chemo standards

Market attractiveness for vinorelbine depends on:

• regimen inclusion in guidelines
• observed clinician adoption
• hospital formulary fit and tender pricing

Commercial projection: what is the outlook for Navelbine through the next 3 to 5 years?

Base case projection

• Flat to low single-digit movement in global brand-like revenue attributable to:
  • generic price compression
  • stable but mature patient demand
  • substitution continuity

Upside scenarios

• formulation or supply-driven share gains in specific geographies
• temporary tender-driven reversion toward established brands where substitution is constrained

Downside scenarios

• accelerated substitution and procurement harmonization to lowest-cost generics
• further pricing pressure as additional ANDA suppliers compete

Key commercial KPIs to watch (actionable monitoring framework)

• Number of ANDA suppliers active by major geography (indicates intensity of substitution)
• Hospital formulary and tender award patterns by procurement cycle
• Oral-to-IV mix shifts (where supported by labeling and practical administration)
• Net price erosion rates in major tenders
• Availability events (manufacturing or logistics) that can transiently shift demand

Key Takeaways

• Navelbine (vinorelbine) remains a mature chemotherapy option in NSCLC and advanced breast cancer, with contemporary clinical activity concentrated in combination and translational studies rather than new pivotal programs.
• Market growth is constrained by generic competition; demand is governed mainly by guideline fit, procurement dynamics, and supply reliability.
• Patent-driven exclusivity is not a primary driver in the current commercial window; ongoing access is mainly shaped by generic penetration and regional tender behavior.
• Near-term (3 to 5 years) commercial outlook is best characterized as flat to low single-digit, with volatility tied to tender allocation and supply.

FAQs

1. What are the most common combination regimens that include vinorelbine for NSCLC and advanced breast cancer?
2. Which vinorelbine dosage form (oral vs IV) typically shows stronger procurement resilience in generics-heavy markets?
3. What real-world evidence endpoints best predict tolerability and treatment discontinuation for vinorelbine-based chemo in routine oncology practice?
4. How does clinician adoption of vinorelbine change when immunotherapy or targeted therapy enters the regimen landscape for eligible patients?
5. What tender and formulary levers most influence Navelbine market share against low-cost generic competitors?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. ClinicalTrials.gov. Studies on vinorelbine (search results for vinorelbine combinations and observational studies).