Lopinavir - PharmaKB

Kaletra(lopinavir)

Kaletra, Lopinavir / Ritonavir, Lopinavir/Ritonavir Mylan (lopinavir) is a small molecule pharmaceutical. Lopinavir was first approved as Kaletra on 2000-09-15. It is used to treat acquired immunodeficiency syndrome in the USA. It has been approved in Europe to treat HIV infections.

Download report

Favorite

COVID-19

Case Study: COVID-19

Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

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

Mock data
Subscribe for the real data

Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
urogenital diseases	D000091642
immune system diseases	D007154

Trade Name

FDA

EMA

Combinations

Kaletra, Lopinavir ritonavir (discontinued: Kaletra, Lopinavir ritonavir)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Lopinavir

Ritonavir

Tradename	Company	Number	Date	Products
KALETRA	AbbVie	N-021251 RX	2000-09-15	1 products, RLD, RS
KALETRA	AbbVie	N-021906 RX	2005-10-28	2 products, RLD, RS

Show 1 discontinued

Labels

FDA

EMA

Brand Name	Status	Last Update
kaletra	New Drug Application	2023-07-06
lopinavir and ritonavir	ANDA	2023-10-20

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
acquired immunodeficiency syndrome	EFO_0000765	D000163	B20

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

J: Antiinfectives for systemic use

— J05: Antivirals for systemic use

— J05A: Direct acting antivirals

— J05AR: Antivirals for treatment of hiv infections, combinations

— J05AR10: Lopinavir and ritonavir

HCPCS

No data

Clinical

Clinical Trials

439 clinical trials

View more details

Mock data
Subscribe for the real data

Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv infections	D015658	EFO_0000764	B20	23	62	79	69	58	274
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	7	8	19	21	19	71
Covid-19	D000086382	—	U07.1	1	22	27	5	18	63
Hiv	D006678	—	O98.7	10	9	10	20	15	60
Infections	D007239	EFO_0000544	—	4	6	11	4	9	33
Coronavirus infections	D018352	EFO_0007224	B34.2	—	8	6	1	7	20
Pneumonia	D011014	EFO_0003106	J18	—	3	5	2	7	15
Tuberculosis	D014376	EFO_0000774	A15-A19	3	6	—	4	1	14
Healthy volunteers/patients	—	—	—	7	—	—	3	2	12
Hepatitis c	D006526	—	B19.2	2	2	2	1	4	11

Show 27 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hepatitis	D006505	—	K75.9	—	1	2	—	2	5
Virus diseases	D014777	—	B34	—	1	1	—	3	5
Severe acute respiratory syndrome	D045169	EFO_0000694	J12.81	—	1	2	—	2	4
Hepatitis a	D006506	EFO_0007305	B15	—	1	1	—	2	4
Respiratory tract infections	D012141	—	J06.9	—	—	2	—	—	2
Community-acquired pneumonia	D000098968	—	—	—	—	2	—	—	2
Respiratory tract diseases	D012140	—	—	—	—	1	—	—	1
Lung diseases	D008171	EFO_0003818	J98.4	—	—	1	—	—	1
Human influenza	D007251	EFO_0007328	J11.1	—	—	1	—	—	1
Hiv-2	D015498	—	—	—	—	1	—	—	1

Show 3 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Respiratory distress syndrome	D012128	EFO_1000637	J80	1	1	—	—	3	4
Viral pneumonia	D011024	EFO_0007541	J12.9	—	1	—	—	3	4
Coronavirus	D017934	—	—	—	1	—	—	2	3
Hepatitis b	D006509	—	—	—	1	—	—	1	2
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	1	—	—	1	2
Neoplasms	D009369	—	C80	1	2	—	—	—	2
Renal insufficiency	D051437	—	N19	—	1	—	—	—	1
Viremia	D014766	—	B34.9	—	1	—	—	—	1
Liver cirrhosis	D008103	EFO_0001422	K74.0	—	1	—	—	—	1
Fibrosis	D005355	—	—	—	1	—	—	—	1

Show 28 more

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pharmacokinetics	D010599	—	—	1	—	—	—	1	2
Insulin resistance	D007333	EFO_0002614	E88.819	1	—	—	—	1	2
Long qt syndrome	D008133	HP_0001657	I45.81	1	—	—	—	—	1
Pharmacological phenomena	D000069437	—	—	1	—	—	—	—	1
Therapeutic equivalency	D013810	—	—	1	—	—	—	—	1
Hypertriglyceridemia	D015228	EFO_0004211	—	1	—	—	—	—	1
Squamous intraepithelial lesions of the cervix	D065310	—	—	1	—	—	—	—	1
Inflammation	D007249	MP_0001845	—	1	—	—	—	—	1
Therapeutics	D013812	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	—	—	—	2	2
Chronic hepatitis c	D019698	EFO_0004220	B18.2	—	—	—	—	1	1
Chronic hepatitis b	D019694	EFO_0004239	B18.1	—	—	—	—	1	1
Wasting syndrome	D019282	—	—	—	—	—	—	1	1
Cachexia	D002100	—	R64	—	—	—	—	1	1
Hemorrhage	D006470	MP_0001914	R58	—	—	—	—	1	1
Heart failure	D006333	EFO_0003144	I50	—	—	—	—	1	1
Hypertension	D006973	EFO_0000537	I10	—	—	—	—	1	1
Menorrhagia	D008595	EFO_0003945	N92.0	—	—	—	—	1	1
Hemophilia a	D006467	EFO_0007267	D66	—	—	—	—	1	1

Show 36 more

Epidemiology

Epidemiological information for investigational and approved indications

View more details

Drug

General

Drug common name	Lopinavir
INN	lopinavir
Description	Lopinavir is a dicarboxylic acid diamide that is amphetamine is substituted on nitrogen by a (2,6-dimethylphenoxy)acetyl group and on the carbon alpha- to nitrogen by a (1S,3S)-1-hydroxy-3-{[(2S)-3-methyl-2-(2-oxotetrahydropyrimidin-1-yl)butanoyl]amino}-4-phenylbutyl group. An antiretroviral of the protease inhibitor class, it is used against HIV infections as a fixed-dose combination with another protease inhibitor, ritonavir. It has a role as an antiviral drug, a HIV protease inhibitor and an anticoronaviral agent. It is a member of amphetamines and a dicarboxylic acid diamide.
Classification	Small molecule
Drug class	antivirals: HIV protease inhibitors (saquinavir type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Cc1cccc(C)c1OCC(=O)N[C@@H](Cc1ccccc1)[C@@H](O)C[C@H](Cc1ccccc1)NC(=O)[C@H](C(C)C)N1CCCNC1=O