Cialis(tadalafil)
Adcirca, Cialis, Entadfi, Tadliq (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
Therapeutic Area | MeSH |
|---|---|
| respiratory tract diseases | D012140 |
| urogenital diseases | D000091642 |
| cardiovascular diseases | D002318 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Adcirca, Cialis, Tadliq (generic drugs available since 2018-05-22)
CombinationsEntadfi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Finasteride
+
Tadalafil
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ENTADFI | Veru | N-215423 RX | 2021-12-09 | 1 products, RLD, RS |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pulmonary hypertension | EFO_0001361 | D006976 | I27.20 |
| vasculogenic impotence | EFO_1001234 | D018783 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Tadalafil, Tadliq, Cmp Dev Llc | |||
| 11382917 | 2038-12-24 | DP | U-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
202 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 | 4 | 5 | 21 | 19 | 12 | 61 |
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | 6 | 5 | 13 | 3 | 2 | 28 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | 3 | 8 | 3 | — | 14 |
| Pulmonary arterial hypertension | D000081029 | 2 | 2 | 2 | 7 | 1 | 13 | ||
| Healthy volunteers/patients | — | 8 | 1 | — | 1 | — | 10 | ||
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | 1 | 3 | — | 5 |
| Duchenne muscular dystrophy | D020388 | 2 | 1 | 2 | 1 | — | 5 | ||
| Premature ejaculation | D061686 | HP_0012876 | F52.4 | — | — | 3 | 1 | — | 4 |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | — | — | — | 2 | 2 | 4 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 1 | — | 1 | — | 3 |
Show 20 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | C61 | — | 1 | 3 | — | — | 4 | |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 1 | 2 | — | — | 3 |
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | — | — | 2 | — | 1 | 3 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.89 | — | — | 1 | — | — | 1 |
| Psychological sexual dysfunctions | D020018 | F52.0 | — | — | 1 | — | — | 1 | |
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | — | 1 | — | — | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | — | — | 1 |
| Insulin resistance | D007333 | EFO_0002614 | — | — | 1 | — | — | 1 | |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | 1 | — | — | 1 |
| Fontan procedure | D018729 | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Squamous cell carcinoma of head and neck | D000077195 | 1 | 3 | — | — | — | 4 | ||
| Head and neck neoplasms | D006258 | 1 | 1 | — | — | 1 | 3 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 2 | — | — | — | 3 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 2 | — | — | 1 | 3 |
| Pulmonary edema | D011654 | EFO_1001134 | J81 | 1 | 1 | — | — | 1 | 2 |
| Cerebral small vessel diseases | D059345 | — | 2 | — | — | — | 2 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | 2 | 2 | — | — | — | 2 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | 2 | 2 | — | — | — | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | — | 1 | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 2 | — | — | — | 2 |
Show 16 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | 1 | — | — | — | — | 1 | |
| Astrocytoma | D001254 | EFO_0000271 | 1 | — | — | — | — | 1 | |
| Smoking | D012907 | EFO_0003768 | F17 | 1 | — | — | — | — | 1 |
| Abdominal neoplasms | D000008 | 1 | — | — | — | — | 1 | ||
| Muscular dystrophies | D009136 | EFO_0000757 | G71.0 | 1 | — | — | — | — | 1 |
| Stress urinary incontinence | D014550 | HP_0010992 | 1 | — | — | — | — | 1 | |
| Fecal incontinence | D005242 | R15 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | — | 2 | 2 |
| Prostatitis | D011472 | EFO_0003830 | N41 | — | — | — | — | 1 | 1 |
| Persistent fetal circulation syndrome | D010547 | EFO_1001103 | P29.3 | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | — | — | — | — | 1 | 1 | ||
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | — | 1 | 1 |
| Brain edema | D001929 | EFO_1000845 | G93.6 | — | — | — | — | 1 | 1 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 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 |
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
Clinical Variant
No data
Financial
Entadfi - Veru
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Adcirca - United Therapeutics
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Cialis - Eli Lilly
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,508 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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47,045 adverse events reported
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