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
Therapeutic Areas
Trade Name
FDA
EMA
Adcirca, Alyq, Cialis, Tadalafil, Tadliq (discontinued: Cialis, Tadalafil)
CombinationsFinasteride tadalafil, 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
Finasteride
+
Tadalafil
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
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
256 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 1 | 1 | 13 | 12 | — | 27 |
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | 1 | 5 | 10 | 2 | — | 17 |
| Hyperplasia | D006965 | EFO_0000536 | — | 1 | 5 | 10 | 2 | — | 17 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 4 | 4 | 1 | 1 | 9 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | 1 | 4 | 1 | — | 5 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | 1 | 2 | 1 | 1 | 5 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | 1 | 1 | — | 1 | 1 | 3 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | 1 | — | 1 | — | 2 |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | — | — | — | — | 1 | — | 1 |
| Vomiting | D014839 | — | R11.1 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | — | — | 1 | — | — | 1 |
| Muscular dystrophies | D009136 | EFO_0000757 | G71.0 | — | — | 1 | — | — | 1 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | 1 | 1 | — | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | 1 | — | — | 1 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Essential hypertension | D000075222 | — | I10 | — | 1 | — | — | — | 1 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | 1 | — | — | — | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 1 | — | — | — | 1 |
| Priapism | D011317 | — | N48.3 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemic optic neuropathy | D018917 | EFO_1000809 | H47.01 | — | — | — | — | 1 | 1 |
| Optic nerve diseases | D009901 | EFO_1001330 | H47.14 | — | — | — | — | 1 | 1 |
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tadalafil |
| INN | tadalafil |
| 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 class | phosphodiesterase type 5 inhibitors (PDE5) inhibitors: (PDE5) inhibitors containing a sulfonamide moiety |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN1CC(=O)N2[C@H](Cc3c([nH]c4ccccc34)[C@H]2c2ccc3c(c2)OCO3)C1=O |
Identifiers
| PDB | — |
| CAS-ID | 171596-29-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL779 |
| ChEBI ID | 71940 |
| PubChem CID | 110635 |
| DrugBank | DB00820 |
| UNII ID | 742SXX0ICT (ChemIDplus, GSRS) |
Target
Agency Approved
PDE5A
PDE5A
Organism
Homo sapiens
Gene name
PDE5A
Gene synonyms
PDE5
NCBI Gene ID
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
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
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
Mouse ortholog
Pde11a (241489)
dual 3',5'-cyclic-AMP and -GMP phosphodiesterase 11A (P0C1Q2)
Variants
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Financial
Revenue by drug
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Cialis – Eli Lilly
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Adcirca – United Therapeutics
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Entadfi – Veru
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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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Safety
Black-box Warning
Black-box warning for: Opsynvi
Adverse Events
Top Adverse Reactions
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37,060 adverse events reported
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