ABRAXANE (paclitaxel)
Abraxane is a microtubule inhibitor indicated for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy (prior therapy should have included an anthracycline unless clinically contraindicated). It is also indicated as first-line treatment for locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation. Additionally, it is indicated as first-line treatment for metastatic adenocarcinoma of the pancreas in combination with gemcitabine.
How ABRAXANE Works
Abraxane is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes them by preventing depolymerization. This stability inhibits the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces the formation of abnormal microtubule "bundles" throughout the cell cycle and multiple asters of microtubules during mitosis, leading to cell cycle arrest and apoptosis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2005-01-07
- PDUFA Date
- 2026-07-11 (46d)
- Patent Cliff
- 2034
- Revenue
- $24M (Q4-2025)
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
ABRAXANE Approval History
What ABRAXANE Treats
5 FDA approvalsOriginally approved for its first indication in 2005 . Covers 5 distinct patient populations.
- Other (5)
ABRAXANE Boxed Warning
SEVERE MYELOSUPPRESSION • Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications (4) ]. • Monitor for neutropenia, which may be severe and result in infection or sepsis [see Warnings and Precautions (5.1 , 5.3) ]. • Perform frequent complete blood cell counts on all patients receiving ABRAXANE [see Warnings and Precautions (5.1 , 5.3) ]. WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxe...
WARNING: SEVERE MYELOSUPPRESSION • Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications (4) ]. • Monitor for neutropenia, which may be severe and result in infection or sepsis [see Warnings and Precautions (5.1 , 5.3) ]. • Perform frequent complete blood cell counts on all patients receiving ABRAXANE [see Warnings and Precautions (5.1 , 5.3) ]. WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning . • Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 . ( 4 ) • Monitor for neutropenia, which may be severe and result in infection or sepsis. ( 5.1 , 5.3 ) • Perform frequent complete blood cell counts on all patients receiving ABRAXANE. ( 5.1 , 5.3 )
ABRAXANE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
1725 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03604991 | NCI-2018-01575 NCI-2018-01575, EA2174 | Ph 2, Ph 3 | suspended | Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery |
| NCT07396324 NEO-ITHRAN | LY2025-422-A | Ph 2 | recruiting | Neoadjuvant QL1706 in Patients With Hormone Receptor Positive, HER2-negative Breast Cancer |
| NCT04310007 | NCI-2020-01541 NCI-2020-01541, EA5191 | Ph 2 | active not recruiting | Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer |
| NCT06058377 | NCI-2023-04566 NCI-2023-04566, S2206 | Ph 3 | recruiting | Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer |
| NCT03606967 | NCI-2018-01581 NCI-2018-01581, 10146 | Ph 2 | recruiting | Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer |
| NCT05422794 | NCI-2022-04956 NCI-2022-04956, DFHCC #22-589 | Ph 1 | recruiting | Testing the Addition of Anti-Cancer Drug, ZEN003694 (ZEN-3694) and PD-1 Inhibitor (Pembrolizumab), to Standard Chemotherapy (Nab-Paclitaxel) Treatment in Patients With Advanced Triple-Negative Breast Cancer |
| NCT07198074 | NCI-2025-06974 NCI-2025-06974, NRG-GY035 | Ph 3 | recruiting | Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer |
| NCT06591650 GCND | Huashan010 | Ph 2 | recruiting | Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer |
| NCT07281417 | NCI-2025-09016 NCI-2025-09016, 10721 | Ph 2 | recruiting | Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma |
| NCT05019716 | NCI-2021-08926 NCI-2021-08926, 10507 | Ph 1, Ph 2 | recruiting | Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma |
| NCT07221474 INTerpath-13 | V940-013 V940-013, U1111-1318-2495 | Ph 2 | recruiting | A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013) |
| NCT07283692 | LY2025-277-A | Ph 2 | recruiting | Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT) |
| NCT04579224 | NCI-2020-07651 NCI-2020-07651, S1937 | Ph 3 | active not recruiting | Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer |
| NCT01081951 results posted | D0810C00041 2009-015970-36 | Ph 2 | active not recruiting | Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer |
| NCT05554380 | NCI-2022-07304 NCI-2022-07304, EAY191-S3 | Ph 2 | suspended | Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With PTEN/AKT Mutations, A ComboMATCH Treatment Trial |
| NCT05685602 | NCI-2022-08984 NCI-2022-08984, 202304010 | Ph 1 | suspended | CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer |
| NCT04090398 | NCI-2019-06088 NCI-2019-06088, 052001 | Ph 2 | active not recruiting | Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones |
| NCT06524544 | NCI-2024-06208 NCI-2024-06208, EA8231 | Ph 3 | recruiting | A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitean-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer |
| NCT05554341 | NCI-2022-07264 NCI-2022-07264, EAY191-E4 | Ph 2 | active not recruiting | Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment Trial |
| NCT07061977 | NCI-2025-04695 NCI-2025-04695, NRG-GY037 | Ph 3 | recruiting | Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer |
| NCT04274426 MIROVA | AGO-OVAR 2.34 2018-004207-39, 2024-516959-40-00 | Ph 2 | active not recruiting | Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer |
| NCT07195734 | NCI-2025-06920 NCI-2025-06920, NRG-HN015 | Ph 2 | recruiting | Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer |
| NCT04704934 | DS8201-A-U306 2020-004559-34 | Ph 3 | active not recruiting | Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04) |
| NCT05673200 | NCI-2022-10810 NCI-2022-10810, 10546 | Ph 1 | recruiting | Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer |
| NCT05256225 | NCI-2022-01540 NCI-2022-01540, NRG-GY026 | Ph 3 | recruiting | Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma |
| NCT03907475 | NCI-2019-01886 NCI-2019-01886, 10292 | Ph 2 | recruiting | Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial |
| NCT06843447 | 5909-003 MK-5909-003, 2024-514674-47-00 | Ph 1, Ph 2 | recruiting | A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003) |
| NCT04267848 | NCI-2020-00751 NCI-2020-00751, A081801 | Ph 3 | recruiting | Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO]) |
| NCT05564377 | NCI-2022-06842 NCI-2022-06842, EAY191 | Ph 2 | recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial |
| NCT06694454 | 10001609 001609-C | Ph 1, Ph 2 | recruiting | Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC) |
| NCT06203600 | NCI-2023-11064 NCI-2023-11064, S2303 | Ph 2, Ph 3 | recruiting | Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial |
| NCT05775289 results posted | BO44178 | Ph 2 | active not recruiting | A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer |
| NCT06448754 eVOLVE-01 | D798KC00001 2023-509482-20-00 | Ph 2 | recruiting | Volrustomig Priming Regimens Exploratory Phase II Platform Study |
| NCT06445972 | 3475-06D 2023-509306-29-00, U1111-1299-8160 | Ph 1, Ph 2 | recruiting | Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06) |
| NCT05420948 | IRB22-0288 | Ph 2 | recruiting | A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer |
| NCT06161025 | DS6000-109 REJOICE-Ovarian01, ENGOT-ov77 | Ph 2, Ph 3 | recruiting | A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
| NCT04245085 ABC-lung results posted | ETOP 15-19 MO40586 | Ph 2 | completed | ABC-lung: Atezolizumab, Bevacizumab and Chemotherapy in EGFR-mutant Non-small Cell Lung Carcinoma |
| NCT02689427 results posted | 2015-0488 NCI-2016-00367, 2015-0488 | Ph 2 | completed | Enzalutamide and Paclitaxel Before Surgery in Treating Patients With Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer |
| NCT03819465 MAGELLAN | D933IC00001 2018-001748-74 | Ph 1 | active not recruiting | A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC |
| NCT06043427 | GA4 | Ph 2 | recruiting | Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma |
| NCT03609047 Appalaches | EORTC 1745-ETF-BCG | Ph 2 | active not recruiting | Adjuvant Palbociclib in Elderly Patients With Breast Cancer |
| NCT06096844 | NCI-2023-08628 NCI-2023-08628, EA5221 | Ph 3 | recruiting | Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial |
| NCT04251533 EPIK-B3 results posted | CBYL719H12301 2024-511931-87-00, 2019-002637-11 | Ph 3 | terminated | Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss |
| NCT06279364 | SKB264-Ⅲ-11 | Ph 3 | recruiting | A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer |
| NCT07060807 | 1022-016 U1111-1317-5490, 2025-520582-51-00 | Ph 3 | recruiting | A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016) |
| NCT06385080 OrigAMI-4 | 61186372HNC2002 61186372HNC2002, 2023-508418-40-00 | Ph 1, Ph 2 | recruiting | A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer |
| NCT05954312 | VVD-130037-001 2023-506199-28-00 | Ph 1 | recruiting | A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors |
| NCT06422143 | 2870-023 2023-510128-66-00, U1111-1301-2790 | Ph 3 | recruiting | Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023] |
| NCT07071337 | SKB264-Ⅲ-13 | Ph 3 | recruiting | A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy |
| NCT07216703 | 2870-036 U1111-1319-9926, 2025-521514-26-00 | Ph 3 | recruiting | A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22) |
Showing 50 of 1725 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ABRAXANE FDA Label Details
Indications & Usage
FDA Label (PDF)ABRAXANE is a microtubule inhibitor indicated for the treatment of: • Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. • Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. • Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcit...
WARNING: SEVERE MYELOSUPPRESSION • Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications (4) ]. • Monitor for neutropenia, which may be severe and result in infection or sepsis [see Warnings and Precautions (5.1 , 5.3) ]. ...
ABRAXANE Patents & Exclusivity
Patents (14 active)
Pro Intelligence Preview
Deep insights for ABRAXANE
Revenue Insights
- • Q4-2025: $24M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 14 active patents
Trial Analysis
- • 578 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment