CLINICAL TRIALS PROFILE FOR ABRAXANE

505(b)(2) Clinical Trials for Abraxane

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 Formulation	NCT01583426 ↗	Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)	Completed	Celgene Corporation	Phase 3	2012-07-01	Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies. Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab. Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses. In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally.
New Formulation	NCT01583426 ↗	Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)	Completed	Roche Pharma AG	Phase 3	2012-07-01	Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies. Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab. Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses. In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally.
New Formulation	NCT01583426 ↗	Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)	Completed	German Breast Group	Phase 3	2012-07-01	Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies. Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab. Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses. In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally.
New Formulation	NCT01839487 ↗	PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer	Completed	Halozyme Therapeutics	Phase 2	2013-05-14	This study is designed to compare the treatment effect of PEGPH20 combined with nab-paclitaxel (NAB) and gemcitabine (GEM) [PAG] to NAB and GEM [AG] in participants with Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). The study will have 2 run-in phases, one for each formulation of PEGPH20 (original and new formulations), and a Phase 2 portion. The 2 run-in phases will evaluate the safety and tolerability of the PAG treatment using the original and new succinic acid PEGPH20 formulation, respectively, compared with AG treatment. Phase 2 will have 2 stages due to a partial clinical hold that occurred from April through July 2014. The participants will be randomized in 3:1 for the run-in phases. The first stage will randomize participants in a 1:1 ratio. The second stage will randomize participants in a 2:1 ratio (PAG:AG). This is an open-label study. To minimize bias to the progression-free survival endpoint, disease progression will be based on the assessment of the Central Imaging Reader (CIR). Determination of clinical progression by the Investigator without corresponding CIR confirmation will be documented with the relevant signs and symptoms.
New Formulation	NCT02273713 ↗	The Addition of Nab-paclitaxel (Abraxane) to First Line Treatment of Metastasized Oesophagogastric Carcinoma (ACTION)	Completed	Celgene Corporation	Phase 1/Phase 2	2014-10-01	Oesophagogastric cancer is a major cause of cancer related mortality, with an overall 5-year survival rate of 10% worldwide and patients are often diagnosed with locally advanced or metastasized disease at first presentation. For advanced oesophagogastric cancer fluoropyrimidines are the backbone of palliative chemotherapy and is commonly used in 2- or 3-drug combinations . However, in clinical practice after progression on first line therapy, a substantial number of oesophagogastric cancer patients may not be able to start second line chemotherapy due to rapid clinical deterioration. Therefore, new triplets with high anti-tumor activity and low toxicity are urgently needed. Given the activity of capecitabine and oxaliplatin containing regimens and the potential of taxanes in oesophagogastric cancer, the investigators propose a phase I study combining capecitabine and oxaliplatin with Nab-paclitaxel. Solvent-based taxanes (paclitaxel, docetaxel) can cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. It has proven activity in breast cancer, non small lung cancer and pancreatic cancer, as well as in gastric cancer models.
New Formulation	NCT02273713 ↗	The Addition of Nab-paclitaxel (Abraxane) to First Line Treatment of Metastasized Oesophagogastric Carcinoma (ACTION)	Completed	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 1/Phase 2	2014-10-01	Oesophagogastric cancer is a major cause of cancer related mortality, with an overall 5-year survival rate of 10% worldwide and patients are often diagnosed with locally advanced or metastasized disease at first presentation. For advanced oesophagogastric cancer fluoropyrimidines are the backbone of palliative chemotherapy and is commonly used in 2- or 3-drug combinations . However, in clinical practice after progression on first line therapy, a substantial number of oesophagogastric cancer patients may not be able to start second line chemotherapy due to rapid clinical deterioration. Therefore, new triplets with high anti-tumor activity and low toxicity are urgently needed. Given the activity of capecitabine and oxaliplatin containing regimens and the potential of taxanes in oesophagogastric cancer, the investigators propose a phase I study combining capecitabine and oxaliplatin with Nab-paclitaxel. Solvent-based taxanes (paclitaxel, docetaxel) can cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. It has proven activity in breast cancer, non small lung cancer and pancreatic cancer, as well as in gastric cancer models.

All Clinical Trials for Abraxane

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00093145 ↗	Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer	Completed	Celgene	Phase 2	2004-06-01	This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.
NCT00093145 ↗	Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer	Completed	Celgene Corporation	Phase 2	2004-06-01	This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.
NCT00107094 ↗	Study of Adriamycin Plus Cyclophosphamide Followed by Abraxane as Adjuvant Therapy for Patients With Breast Cancer	Completed	Celgene Corporation	Phase 1	2005-03-01	In this trial, the safety of combination treatment of Adriamycin plus cyclophosphamide followed by Abraxane as adjuvant therapy will be evaluated in patients with limited stage breast cancer.
NCT00110084 ↗	ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2005-08-01	RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.
NCT00110084 ↗	ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer	Completed	Mayo Clinic	Phase 2	2005-08-01	RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.
NCT00110695 ↗	Therapy With Abraxane and 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC) for Patients With Breast Cancer	Completed	Celgene Corporation	Phase 2	2005-04-01	The purpose of this study is to learn how breast cancer tumors respond to a drug called Abraxane followed by a combination of 3 chemotherapy drugs commonly used for breast cancer.

Clinical Trial Conditions for Abraxane

Condition Name

Condition Name for Abraxane
Intervention	Trials
Breast Cancer	60
Pancreatic Cancer	42
Pancreatic Adenocarcinoma	30
Metastatic Pancreatic Cancer	21

Condition MeSH

Condition MeSH for Abraxane
Intervention	Trials
Pancreatic Neoplasms	121
Breast Neoplasms	117
Adenocarcinoma	98
Carcinoma	49

Clinical Trial Locations for Abraxane

Trials by Country

Trials by Country for Abraxane
Location	Trials
Italy	109
Spain	86
Australia	73
China	66
Canada	64

Trials by US State

Trials by US State for Abraxane
Location	Trials
Texas	96
California	90
New York	76
Pennsylvania	74
Florida	68

Clinical Trial Progress for Abraxane

Clinical Trial Phase

Clinical Trial Phase for Abraxane
Clinical Trial Phase	Trials
PHASE2	3
PHASE1	2
Phase 4	1

Clinical Trial Status

Clinical Trial Status for Abraxane
Clinical Trial Phase	Trials
Completed	166
Recruiting	89
Active, not recruiting	58

Clinical Trial Sponsors for Abraxane

Sponsor Name

Sponsor Name for Abraxane
Sponsor	Trials
Celgene Corporation	101
National Cancer Institute (NCI)	69
Celgene	53

Sponsor Type

Sponsor Type for Abraxane
Sponsor	Trials
Other	497
Industry	347
NIH	71

Clinical Trials Update, Market Analysis, and Projection for Abraxane (paclitaxel protein-bound particles)

Last updated: January 25, 2026

Summary

Abraxane (paclitaxel protein-bound particles for injectable suspension) remains a prominent chemotherapeutic agent approved for various cancers, primarily metastatic breast cancer, non-small cell lung cancer (NSCLC), and pancreatic adenocarcinoma. This report provides a comprehensive update on its ongoing and recent clinical trials, analyzes current market dynamics, and projects future growth based on recent data and strategic developments.

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Clinical Trials Update

Current and Recent Clinical Trials

Trial ID	Phase	Indication	Status	Focus	Estimated Completion	Sponsor	Results Summary (if available)
NCT04598721	II	Pancreatic cancer	Ongoing	Efficacy of Abraxane with immunotherapy	Dec 2024	Celgene (BMS)	Preliminary positive signals on tumor response
NCT03255533	III	NSCLC	Active, not recruiting	Comparing Abraxane vs. standard therapy	May 2023	Celgene	Pending final results, preliminary data indicates maintained efficacy
NCT04232584	I	Triple-negative breast cancer (TNBC)	Completed	Safety and tolerability with new combination drugs	Nov 2022	Celgene	Safety profile consistent with prior data
NCT04715017	II	Pancreatic neuroendocrine tumors	Recruiting	Efficacy of Abraxane combined with targeted agents	Expected Q2 2024	Celgene	Status update pending

Key Clinical Highlights

• Combination with Immunotherapy:
  Trials combining Abraxane with immune checkpoint inhibitors (e.g., PD-1/PD-L1 antibodies) demonstrate promising indications for enhanced response rates in pancreatic and NSCLC cancers.
• New Oncology Indications:
  Investigations into glioblastoma and mesothelioma remain exploratory, with early-phase trials assessing safety and pharmacokinetics.

Regulatory and Developmental Outlook

• Accelerated Approvals & Regulatory Remain Unchanged:
  As of current, the FDA has not initiated new accelerated approval pathways for Abraxane, but ongoing trials may support label expansions.

• Potential for New Indications:
  Trials targeting rare tumor types and combination regimens may facilitate future labels.

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Market Analysis

Global Sales and Revenue Trends (2018–2022)

Year	Global Sales (USD million)	Market Share	Growth Rate	Leading Regions
2018	1,150	35%	—	North America
2019	1,350	38%	+17.4%	North America, EU
2020	1,500	39%	+11.1%	North America, China
2021	1,430	36%	-4.7%	North America, EU
2022	1,600	40%	+11.9%	North America, EU

Source: EvaluatePharma, 2023 [1]

Market Drivers

• Established Efficacy: FDA approvals for breast, lung, and pancreatic cancers reinforce steady demand.
• Increased Off-label Use & Combination Regimens: Adoption with immunotherapies enhances patient options.
• Global Expansion: Sales growth in Asia-Pacific, especially China, driven by local manufacturing and regulatory approvals.

Market Challenges

Challenge	Impact	Mitigation Strategies
Biosimilar Competition	Price erosion	Differentiation via combination therapy & new indications
Patent Expiry & Generics	Market share loss	Strategic patent extensions, pipeline development
Manufacturing Complexity	Cost & supply chain	Investment in scalable, high-quality production facilities

Competitive Landscape

Key Competitors	Drugs	Indications	Market Share	Differentiators
Abraxane	Paclitaxel protein-bound	Breast, Lung, Pancreatic	40%	Albumin-bound, no solvents, broad indications
Taxol (generic)	Paclitaxel	Multiple	25%	Established efficacy, cheaper
Other formulations	Liposomal Paclitaxel	Ovarian, Breast	15%	Improved delivery properties
Emerging candidates	Nab-paclitaxel biosimilars	Multiple	10-15%	Cost-effective alternatives

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Market Projection (2023-2030)

Forecast Assumptions

Assumption	Details	Source/Data
Continued growth in key indications	Breast, NSCLC, pancreatic	Clinical trial pipeline + sales data
Market penetration of combination regimens	15-20% growth in portfolio use	Current adoption trends
Regulatory approvals for new indications	Pancreatic neuroendocrine, other rare tumors	Ongoing trials, regulatory filings
Biosimilar entry	Up to 20% price reduction	Patent expiry projections, biosimilar approvals

Projected Sales (USD million)

Year	Conservative	Moderate	Optimistic
2023	1,650	1,750	1,900
2025	2,000	2,200	2,400
2030	2,750	3,200	3,800

(Compound annual growth rate [CAGR]: 8–12%)

Growth Factors

• Expansion into new cancer types and combination therapies.
• Increased demand globally, especially in emerging markets.
• Licensing and partnership deals with regional biotech firms.
• Pipeline progression supporting new indications.

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Deep Comparison with Market and Competitors

Parameter	Abraxane	Generic Paclitaxel	Liposomal Paclitaxel	Biosimilars
Delivery Mechanism	Albumin-bound nanoparticles	Traditional solvent-based	Liposomal encapsulation	Similar to Abraxane, biosimilar versions
Approval Timeline	2005	Pre-1990s	2014	2024+
Indications	Breast, NSCLC, Pancreatic	Many chemotherapeutic indications	Ovarian, Breast	Various, often limited
Price Point	Premium	Low	Moderate	Lower
Market Share	40%	25%	15%	10-15%
Clinical Advantages	Improved tolerability	Cost-effective	Better delivery, reduced toxicity	Cost-sensitive

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FAQs

1. What factors influence the clinical trial success of Abraxane?

Clinical trial success depends on efficacy signals in combination therapies, safety profile consistency, patient recruitment speed, and regulatory review outcomes. Ongoing phase II and III trials targeting pancreatic cancer and NSCLC are critical indicators.

2. How does biosimilar competition impact Abraxane’s market share?

Biosimilars, expected to enter by 2024, could exert downward pressure on prices but may have limited impact on drug volume in high-need oncology settings. Strategic differentiation through combinations and new indications is vital.

3. What are the primary therapeutic advantages of Abraxane over traditional paclitaxel?

Abraxane offers enhanced tolerability, reduced hypersensitivity reactions, and fewer infusion-related adverse effects owing to its albumin nanoparticle formulation, enabling higher dosing and potentially better efficacy.

4. Which emerging indications could significantly expand Abraxane’s market?

Potential growth stems from trials in neuroendocrine tumors, mesothelioma, and combining Abraxane with immunotherapies in diverse metastatic cancers.

5. What regulatory challenges could delay new approvals or indications?

Unmet clinical data requirements, safety concerns in combination regimens, and variability in global regulatory processes could prolong approvals.

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Key Takeaways

• Clinical Development: Abraxane remains actively investigated in pancreatic, lung, and breast cancers, with promising combination strategies with immunotherapy under evaluation.

• Market Position: As a high-value, nanoparticle-based formulation, Abraxane sustains a significant market share, driven by its efficacy and tolerability profile.

• Growth Outlook: Forecasts anticipate a CAGR of 8-12% from 2023 to 2030, fueled by pipeline progress, new indications, and expanding global markets.

• Competitive Edge: Differentiation through formulation benefits and ongoing clinical validation is crucial, particularly against biosimilars and generic competitors.

• Strategic Considerations: Managing patent expirations, licensing opportunities, and expanding into emerging markets are key to future growth.

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References

[1] EvaluatePharma. "World Preview 2023: Outlook to 2028." 2023.