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Drug ReportsTadalafil
Cialis(tadalafil)
Adcirca, Alyq, Chewtadzy, Cialis, Opsynvi, Tadalafil, Tadliq, Talmanco (tadalafil) is a small molecule pharmaceutical. Tadalafil was first approved as Cialis on 2002-11-12. It is used to treat pulmonary hypertension and vasculogenic impotence in the USA. It has been approved in Europe to treat erectile dysfunction and pulmonary hypertension. The pharmaceutical is active against cGMP-specific 3',5'-cyclic phosphodiesterase. In addition, it is known to target dual 3',5'-cyclic-AMP and -GMP phosphodiesterase 11A.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
urogenital diseasesD000091642
cardiovascular diseasesD002318
mental disordersD001523
Trade Name
FDA
EMA
Adcirca, Alyq, Cialis, Tadalafil, Tadliq (discontinued: Cialis, Tadalafil)
Combinations
Opsynvi (discontinued: Entadfi, Finasteride tadalafil)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tadalafil
Tradename
Company
Number
Date
Products
TADLIQCMP PharmaN-214522 RX2022-06-17
1 products, RLD, RS
ADCIRCAEli LillyN-022332 RX2009-05-22
1 products, RLD, RS
CIALISEli LillyN-021368 RX2003-11-21
3 products, RLD, RS
Show 1 discontinued
Finasteride
+
Tadalafil
Tradename
Company
Number
Date
Products
ENTADFIOnconetixN-215423 DISCN2021-12-09
1 products, RLD
Hide discontinued
Macitentan
+
Tadalafil
Tradename
Company
Number
Date
Products
OPSYNVIActelionN-218490 RX2024-03-22
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
adcircaNew Drug Application2024-11-13
alyqANDA2024-01-10
cialisNew Drug Application2024-11-13
entadfiNew Drug Application2023-01-12
n/aANDA2024-12-20
opsynviNew Drug Application2024-04-02
tadalafilANDA2025-01-03
tadliqNew Drug Application2022-10-17
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pulmonary hypertensionEFO_0001361D006976I27.20
vasculogenic impotenceEFO_1001234D018783—
prostatic neoplasms—D011471C61
prostatic hyperplasiaEFO_0000284D011470N40
alopeciaHP_0002293D000505L64
hirsutismHP_0001007D006628L68.0
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Tadalafil, Tadliq, Cmp Dev Llc
113829172038-12-24DPU-3397
116665762038-12-24DPU-3397
ATC Codes
C: Cardiovascular system drugs
— C02: Antihypertensives
— C02K: Other antihypertensives in atc
— C02KX: Antihypertensives for pulmonary arterial hypertension
— C02KX52: Ambrisentan and tadalafil
G: Genito urinary system and sex hormones
— G04: Urologicals
— G04B: Urologicals
— G04BE: Drugs used in erectile dysfunction
— G04BE08: Tadalafil
— G04C: Drugs used in benign prostatic hypertrophy
— G04CA: Alpha-adrenoreceptor antagonists, benign prostatic hypertrophy
— G04CA54: Tamsulosin and tadalafil
HCPCS
No data
Clinical
Clinical Trials
250 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10——31—4
Pulmonary arterial hypertensionD000081029————21—3
Familial primary pulmonary hypertensionD065627—I27.0——21—3
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary hypertensionD006976EFO_0001361I27.20——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———3————3
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTadalafil
INNtadalafil
Description
Tadalafil is a pyrazinopyridoindole that is 2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione substituted at position 2 by a methyl group and at position 6 by a 1,3-benzodioxol-5-yl group (the 6R,12aR-diastereomer). A phosphodiesterase V inhibitor inhibitor, currently marketed in pill form for treating erectile dysfunction under the name Cialis; and under the name Adcirca for the treatment of pulmonary arterial hypertension. It has a role as an EC 3.1.4.35 (3',5'-cyclic-GMP phosphodiesterase) inhibitor and a vasodilator agent. It is a pyrazinopyridoindole and a member of benzodioxoles.
Classification
Small molecule
Drug classphosphodiesterase type 5 inhibitors (PDE5) inhibitors: (PDE5) inhibitors containing a sulfonamide moiety
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN1CC(=O)N2[C@H](Cc3c([nH]c4ccccc34)[C@H]2c2ccc3c(c2)OCO3)C1=O
Identifiers
PDB—
CAS-ID171596-29-5
RxCUI—
ChEMBL IDCHEMBL779
ChEBI ID71940
PubChem CID110635
DrugBankDB00820
UNII ID742SXX0ICT (ChemIDplus, GSRS)
Target
Agency Approved
PDE5A
PDE5A
Organism
Homo sapiens
Gene name
PDE5A
Gene synonyms
PDE5
NCBI Gene ID
8654
Protein name
cGMP-specific 3',5'-cyclic phosphodiesterase
Protein synonyms
CGB-PDE, cGMP-binding cGMP-specific 3',5'-cyclic nucleotide phosphodiesterase, cGMP-binding cGMP-specific phosphodiesterase, cGMP-specific phosphodiesterase PDE5A2, cGMP-specific phosphodiesterase type 5A, phosphodiesterase 5A, cGMP-specific, phosphodiesterase isozyme 5
Uniprot ID
Q9Y6Z6
Mouse ortholog
Pde5a (242202)
cGMP-specific 3',5'-cyclic phosphodiesterase (Q8CG03)
Alternate
PDE11A
PDE11A
Organism
Homo sapiens
Gene name
PDE11A
Gene synonyms
NCBI Gene ID
50940
Protein name
dual 3',5'-cyclic-AMP and -GMP phosphodiesterase 11A
Protein synonyms
cAMP and cGMP cyclic nucleotide phosphodiesterase 11A, cAMP and cGMP phosphodiesterase 11A
Uniprot ID
Q9HCR9
Mouse ortholog
Pde11a (241489)
dual 3',5'-cyclic-AMP and -GMP phosphodiesterase 11A (P0C1Q2)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Cialis – Eli Lilly
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Entadfi – Veru
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Adcirca – United Therapeutics
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Tabular view
Estimated US medical usage
Tadalafil
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,998 documents
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Safety
Black-box Warning
Black-box warning for: Opsynvi
Adverse Events
Top Adverse Reactions
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37,146 adverse events reported
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