Paclitaxel - PharmaKB

Taxol, Paxene(paclitaxel)

Abraxane, Apealea, Paclitaxel, Pazenir (paclitaxel) is a small molecule pharmaceutical. Paclitaxel was first approved as Taxol on 1992-12-29. It is used to treat breast neoplasms, kaposi sarcoma, non-small-cell lung carcinoma, and ovarian neoplasms in the USA. It has been approved in Europe to treat breast neoplasms, kaposi sarcoma, non-small-cell lung carcinoma, ovarian neoplasms, and pancreatic neoplasms. The pharmaceutical is active against tubulin beta chain. In addition, it is known to target toll-like receptor 4 and nuclear receptor subfamily 1 group I member 2.

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Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
neoplasms	D009369
digestive system diseases	D004066
respiratory tract diseases	D012140
urogenital diseases	D000091642
skin and connective tissue diseases	D017437
endocrine system diseases	D004700

Trade Name

FDA

EMA

Abraxane, Paclitaxel (discontinued: Paclitaxel, Taxol)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Paclitaxel

Tradename	Company	Number	Date	Products
PACLITAXEL	American Regent	N-211875 RX	2022-07-27	1 products, RLD, RS
ABRAXANE	Bristol Myers Squibb	N-021660 RX	2005-01-07	1 products, RLD, RS
PACLITAXEL	Teva	N-216338 RX	2023-05-11	1 products, RLD, RS

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Labels

FDA

EMA

Brand Name	Status	Last Update
abraxane	New Drug Application	2022-10-31
paclitaxel	ANDA	2024-10-01
paclitaxel injection,	ANDA	2009-07-02
paclitaxel protein bound particles albumin bound	New Drug Application	2023-05-31
paclitaxel protein-bound particles for injectable suspension (albumin-bound)	NDA authorized generic	2022-04-01

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
breast neoplasms	EFO_0003869	D001943	C50
ovarian neoplasms	EFO_0003893	D010051	C56
non-small-cell lung carcinoma	—	D002289	—
kaposi sarcoma	—	D012514	C46

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Paclitaxel, Abraxane, Bristol-Myers
9511046	2034-01-12		U-1434
9393318	2032-03-04		U-1290
9597409	2032-03-04		U-1290
8034375	2026-08-13		U-1290
7758891	2026-02-21		U-1434
8268348	2026-02-21		U-1290
9101543	2026-02-21		U-1434
7820788	2024-10-27	DP	U-1092, U-1290, U-1434

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01C: Plant alkaloids and other natural products, antineoplastic drugs

— L01CD: Taxanes, antineoplastic

— L01CD01: Paclitaxel

— L01CD03: Paclitaxel poliglumex

— L01CD51: Paclitaxel and encequidar

HCPCS

Code	Description
J9264	Injection, paclitaxel protein-bound particles, 1 mg
J9267	Injection, paclitaxel, 1 mg
S1016	Non-pvc (polyvinyl chloride) intravenous administration set, for use with drugs that are not stable in pvc e.g., paclitaxel

Clinical

Clinical Trials

5508 clinical trials

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Indications Phases 4

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Indications Phases 3

No data

Indications Phases 2

No data

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Breast neoplasms	D001943	EFO_0003869	C50	1	—	—	—	—	1

Indications Without Phase

No data

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Paclitaxel
INN	paclitaxel
Description	Paclitaxel is a tetracyclic diterpenoid isolated originally from the bark of the Pacific yew tree, Taxus brevifolia. It is a mitotic inhibitor used in cancer chemotherapy. Note that the use of the former generic name 'taxol' is now limited, as Taxol is a registered trade mark. It has a role as a microtubule-stabilising agent, a metabolite, a human metabolite and an antineoplastic agent. It is a tetracyclic diterpenoid and a taxane diterpenoid. It is functionally related to a baccatin III.
Classification	Small molecule
Drug class	antineoplastics, taxane derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(=O)O[C@H]1C(=O)[C@]2(C)[C@@H](O)C[C@H]3OC[C@@]3(OC(C)=O)[C@H]2[C@H](OC(=O)c2ccccc2)[C@]2(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C

Identifiers

PDB	—
CAS-ID	33069-62-4
RxCUI	—
ChEMBL ID	CHEMBL428647
ChEBI ID	45863
PubChem CID	36314
DrugBank	DB01229
UNII ID	P88XT4IS4D (ChemIDplus, GSRS)

Target

Agency Approved

TUBB

Organism

Homo sapiens

Gene name

TUBB

Gene synonyms

TUBB5

NCBI Gene ID

203068

Protein name

tubulin beta chain

Protein synonyms

beta Ib tubulin, epididymis secretory sperm binding protein, tubulin beta-1 chain, Tubulin beta-5 chain, tubulin, beta polypeptide

Uniprot ID

Q9CY33

Mouse ortholog

Tubb5 (22154)

tubulin beta-5 chain (Q3UF52)

Alternate

TLR4

NR1I2

Organism

Homo sapiens

Gene name

TLR4

Gene synonyms

NCBI Gene ID

7099

Protein name

toll-like receptor 4

Protein synonyms

CD284, homolog of Drosophila toll, hToll, toll like receptor 4 protein

Uniprot ID

Q9UM57

Mouse ortholog

Tlr4 (21898)

toll-like receptor 4 (Q9Z203)

Variants

No data

Financial

Revenue by drug

€

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Abraxane – Bristol Myers Squibb

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Abraxane – Celgene

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Tabular view

Estimated US medical usage

No data

Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 86,165 documents

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Safety

Black-box Warning

Black-box warning for: Abraxane, Paclitaxel, Paclitaxel injection,, Paclitaxel protein bound particles albumin bound, Paclitaxel protein-bound particles for injectable suspension (albumin-bound)

Adverse Events

Top Adverse Reactions

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95,748 adverse events reported

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