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Paclitaxel-albumin
Paclitaxel-albumin is a Taxane; nanoparticle chemotherapy Small molecule drug developed by Sun Yat-sen University. It is currently in Phase 3 development for Metastatic breast cancer, Non-small cell lung cancer, Ovarian cancer. Also known as: albumin paclitaxel, Injectable paclitaxel (albumin bound).
Paclitaxel-albumin is a nanoparticle formulation of the chemotherapy drug paclitaxel bound to human serum albumin that stabilizes microtubules and arrests cell division in cancer cells.
Paclitaxel-albumin is a formulation of paclitaxel that is stabilized with albumin, a protein that acts as a bilirubin sequestering agent. It has been studied in clinical trials for various types of cancer, including triple negative breast cancer, adenocarcinoma of unknown primary, and gastric adenocarcinoma.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Paclitaxel-albumin |
|---|---|
| Also known as | albumin paclitaxel, Injectable paclitaxel (albumin bound) |
| Sponsor | Sun Yat-sen University |
| Drug class | Taxane; nanoparticle chemotherapy |
| Target | β-tubulin (microtubule) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Paclitaxel binds to β-tubulin and prevents microtubule depolymerization, causing cell cycle arrest in the G2/M phase and triggering apoptosis. The albumin nanoparticle formulation improves drug solubility and allows for higher doses with potentially reduced toxicity compared to conventional paclitaxel, and may enhance tumor uptake through albumin-binding protein interactions.
Approved indications
- Metastatic breast cancer
- Non-small cell lung cancer
- Ovarian cancer
Common side effects
- Neutropenia
- Peripheral neuropathy
- Anemia
- Thrombocytopenia
- Alopecia
- Myalgia/arthralgia
Key clinical trials
- Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
- A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) (PHASE3)
- Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (PHASE2)
- Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer (PHASE2)
- Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (PHASE3)
- Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023] (PHASE3)
- A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18) (PHASE1)
- Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Paclitaxel-albumin CI brief — competitive landscape report
- Paclitaxel-albumin updates RSS · CI watch RSS
- Sun Yat-sen University portfolio CI
Frequently asked questions about Paclitaxel-albumin
What is Paclitaxel-albumin?
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What is Paclitaxel-albumin used for?
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Is Paclitaxel-albumin also known as anything else?
What drug class is Paclitaxel-albumin in?
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What does Paclitaxel-albumin target?
Related
- Drug class: All Taxane; nanoparticle chemotherapy drugs
- Target: All drugs targeting β-tubulin (microtubule)
- Manufacturer: Sun Yat-sen University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic breast cancer
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Ovarian cancer
- Also known as: albumin paclitaxel, Injectable paclitaxel (albumin bound)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing