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paclitaxel 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antineoplastics, taxane derivatives	2044	33069-62-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: paclitaxel (-)-Paclitaxel abraxane capxol cyclopax ebetaxel genaxol mitotax padexol plaxicel taxol Taxol A Tocosol Paclitaxel nabpaclitaxel ABI-007 nab-paclitaxel	A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death. Molecular weight: 853.92 Formula: C47H51NO14 CLOGP: 3.88 LIPINSKI: 2 HAC: 15 HDO: 4 TPSA: 221.29 ALOGS: -5.19 ROTB: 14 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

paclitaxel
(-)-Paclitaxel
abraxane
capxol
cyclopax
ebetaxel
genaxol
mitotax
padexol
plaxicel
taxol
Taxol A
Tocosol Paclitaxel
nabpaclitaxel
ABI-007
nab-paclitaxel

A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.

Molecular weight: 853.92
Formula: C47H51NO14
CLOGP: 3.88
LIPINSKI: 2
HAC: 15
HDO: 4
TPSA: 221.29
ALOGS: -5.19
ROTB: 14

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	6.50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	6.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	5.54 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	5 %	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	3 L/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	11 hours	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.12 %	Lombardo F, Berellini G, Obach RS

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Approvals:

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Date	Agency	Company
Dec. 29, 1992	FDA	HQ SPCLT PHARMA
May 10, 2019	EMA	TEVA BV
Sept. 20, 2019	PMDA	Taiho Pharmaceutical Co., Ltd.

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FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	2157.01	13.12	1723	156790	80398	63250111
Neutropenia	1944.61	13.12	2286	156227	172719	63157790
Neuropathy peripheral	1866.56	13.12	1827	156686	111840	63218669
Disease progression	1523.36	13.12	1699	156814	121059	63209450
Metastases to liver	1186.72	13.12	738	157775	22901	63307608
Myelosuppression	1157.16	13.12	727	157786	22976	63307533
Febrile neutropenia	1139.32	13.12	1440	157073	117009	63213500
Metastases to bone	1131.10	13.12	686	157827	20333	63310176
Erythema	1024.51	13.12	1684	156829	174067	63156442
Flushing	976.68	13.12	1066	157447	74021	63256488

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	763.86	15.78	798	52417	87248	34816468
Febrile neutropenia	661.07	15.78	921	52294	135928	34767788
Neutropenia	629.67	15.78	967	52248	155811	34747905
Interstitial lung disease	449.93	15.78	525	52690	64757	34838959
Neuropathy peripheral	414.04	15.78	569	52646	82694	34821022
Disease progression	400.15	15.78	643	52572	107434	34796282
Leukopenia	294.97	15.78	418	52797	62438	34841278
Anaemia	291.00	15.78	896	52319	232439	34671277
Neutrophil count decreased	288.72	15.78	372	52843	50732	34852984
Thrombocytopenia	254.15	15.78	661	52554	155586	34748130

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Neuropathy peripheral	2115.26	12.58	2069	179141	139236	79423942
Malignant neoplasm progression	1908.93	12.58	1923	179287	134067	79429111
Neutropenia	1889.80	12.58	2766	178444	284944	79278234
Febrile neutropenia	1304.47	12.58	2072	179138	228927	79334251
Disease progression	1268.86	12.58	1814	179396	182548	79380630
Myelosuppression	1163.96	12.58	862	180348	39434	79523744
Flushing	1071.85	12.58	1156	180054	87112	79476066
Erythema	1009.15	12.58	1814	179396	221476	79341702
Anaemia	1005.70	12.58	2735	178475	442280	79120898
Neutrophil count decreased	942.11	12.58	1114	180096	92845	79470333

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L01CD01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS Taxanes
ATC	L01CD51	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS Taxanes
CHEBI has role	CHEBI:25212	metabolites
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:61950	microtubule stabilizing role
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
FDA EPC	N0000175592	Microtubule Inhibitor
FDA PE	N0000175085	Microtubule Inhibition
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D050256	Antimitotic Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Ocular hypertension	indication	4210003	DOID:9282
Hypertensive disorder	indication	38341003	DOID:10763
Open-angle glaucoma	indication	84494001	DOID:1067
Secondary malignant neoplasm of pancreas	indication	94459006
Kaposi's sarcoma	indication	109385007
Non-small cell lung cancer	indication	254637007	DOID:3908
Carcinoma of breast	indication	254838004	DOID:3459
Carcinoma of fallopian tube	indication	276870001	DOID:1963
Malignant tumor of cervix	indication	363354003	DOID:4362
Malignant tumor of ovary	indication	363443007	DOID:2394

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.47	acidic
pKa2	12.08	acidic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG/VIAL	ABRAXANE	BRISTOL-MYERS	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	7923536	Dec. 9, 2023	TREATMENT OF BREAST CANCER
100MG/VIAL	ABRAXANE	BRISTOL-MYERS	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	7923536	Dec. 9, 2023	TREATMENT OF LUNG CANCER
100MG/VIAL	ABRAXANE	BRISTOL-MYERS	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	7923536	Dec. 9, 2023	TREATMENT OF PANCREATIC CANCER
100MG/VIAL	ABRAXANE	BRISTOL-MYERS	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	8138229	Dec. 9, 2023	TREATMENT OF BREAST CANCER
100MG/VIAL	ABRAXANE	BRISTOL-MYERS	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	8138229	Dec. 9, 2023	TREATMENT OF LUNG CANCER
100MG/VIAL	ABRAXANE	BRISTOL-MYERS	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	8138229	Dec. 9, 2023	TREATMENT OF PANCREATIC CANCER
100MG/VIAL	ABRAXANE	BRISTOL-MYERS	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	8314156	Dec. 9, 2023	TREATMENT OF LUNG CANCER
100MG/VIAL	ABRAXANE	BRISTOL-MYERS	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	8314156	Dec. 9, 2023	TREATMENT OF PANCREATIC CANCER
100MG/VIAL	ABRAXANE	BRISTOL-MYERS	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	7820788	Oct. 27, 2024	TREATMENT OF BREAST CANCER
100MG/VIAL	ABRAXANE	BRISTOL-MYERS	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	7820788	Oct. 27, 2024	TREATMENT OF LUNG CANCER

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG/VIAL	ABRAXANE	BRISTOL-MYERS	N021660	Jan. 7, 2005	RX	POWDER	INTRAVENOUS	June 6, 2023	PEDIATRIC EXCLUSIVITY

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Tubulin beta	Tumour-associated antigen	P07437 Q9H4B7 Q13885 Q9BVA1 Q13509 P04350 P68371 Q9BUF5 Q3ZCM7	TBB5_HUMAN TBB1_HUMAN TBB2A_HUMAN TBB2B_HUMAN TBB3_HUMAN TBB4A_HUMAN TBB4B_HUMAN TBB6_HUMAN TBB8_HUMAN	INHIBITOR	EC50	8.05	IUPHAR	SCIENTIFIC LITERATURE
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		IC50	5.59	CHEMBL
Nuclear receptor subfamily 1 group I member 2	Nuclear hormone receptor	O75469	NR1I2_HUMAN	AGONIST	EC50	5.30	IUPHAR
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN		Ki	5.83	DRUG MATRIX
Bile salt export pump	Transporter	O95342	ABCBB_HUMAN				WOMBAT-PK
Tubulin beta chain	Structural	P07437	TBB5_HUMAN	INHIBITOR	EC50	8.05	IUPHAR
Tyrosine-protein kinase Fyn	Kinase	P06241	FYN_HUMAN		IC50	4.62	DRUG MATRIX
Receptor tyrosine-protein kinase erbB-2	Kinase	P04626	ERBB2_HUMAN		IC50	4.95	DRUG MATRIX
Multidrug resistance-associated protein 7	Transporter	Q5T3U5	MRP7_HUMAN				WOMBAT-PK
Substance-K receptor	GPCR	P21452	NK2R_HUMAN		Ki	5.69	DRUG MATRIX

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External reference:

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ID	Source
TA1	PDB_CHEM_ID
004116	NDDF
196466	RXNORM
2296	MMSL
2770	IUPHAR_LIGAND_ID
36314	PUBCHEM_CID
387374002	SNOMEDCT_US
4020736	VUID
4020736	VANDF
42243	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0517-4300	INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION	100 mg	INTRAVENOUS	NDA	30 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3213	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3213	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3216	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3216	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3217	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3218	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-3218	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-4764	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections
Paclitaxel	HUMAN PRESCRIPTION DRUG LABEL	1	0703-4768	INJECTION, SOLUTION, CONCENTRATE	6 mg	INTRAVENOUS	ANDA	16 sections

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