Sofosbuvir
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2013
- First approval year
- 2013
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Sofosbuvir
- Molecular weight
- 529.46
- Structure (SMILES)
- CC(C)OC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@H](n2ccc(=O)[nH]c2=O)[C@](C)(F)[C@@H]1O)Oc1ccccc1
- psi 7977 gs 7977
- Psi-7977, gs-7977
- sofosbuvir component of epclusa
- Sofosbuvir component of epclusa
- sofosbuvir component of harvoni
- Sofosbuvir component of harvoni
- sofosbuvir component of vosevi
- Sofosbuvir component of vosevi
- sovaldi
- Sovaldi
- epclusa component sofosbuvir
- EPCLUSA COMPONENT SOFOSBUVIR
- gs 7977
- GS-7977
- gs7977
- GS7977
- harvoni component sofosbuvir
- HARVONI COMPONENT SOFOSBUVIR
- l alanine n p s 2 r 2 deoxy 2 fluoro 2 methyl p phenyl 5 uridylyl 1 methylethyl ester
- L-ALANINE, N-((P(S),2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL)-, 1-METHYLETHYL ESTER
- psi 7977
- PSI-7977
- PSI-7977 (GS7977)
- sof
- SOF
- sof and dcv
- sofosbuvir
- Sofosbuvir
- Sofosbuvir (Part 2)
- sofosbuvir (SOF)
- Sofosbuvir (SOF)
- sofosbuvir [INN]
- SOFOSBUVIR [JAN]
- SOFOSBUVIR [MI]
- SOFOSBUVIR [ORANGE BOOK]
And 21 more, listed on the interactive page.
- CAS registry numbers
- 1190307-88-0
- ChEMBL ID
- CHEMBL1259059
- InChIKey
- TTZHDVOVKQGIBA-IQWMDFIBSA-N
- PubChem compound IDs
- 45375808
- RxNorm IDs (RxCUI)
- 1484911
- FDA ingredient codes (UNII)
- WJ6CA3ZU8B
- J05AP08
- J05AX15
Sources for recorded values
- Applicant
- GILEAD SCIENCES INC
- Approval date
- 6 Dec 2013
- Application number
- NDA204671
- Status
- Authorised
- Status date
- 16 Jan 2014
- Authorisation date
- 16 Jan 2014
- Approved indications
- Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1. Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
- Product number
- EMEA/H/C/002798
- Authorisation holder
- Gilead Sciences Ireland UC
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- Yes
- Exceptional circumstances
- No
Therapeutic areas
- Hepatitis C, Chronic
European medicines record
- Patents
- 66
- Designations
- 6
- Earliest recorded loss of exclusivity
- 1 Dec 2037
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- sofosbuvir
- Type
- Synthetic organic
- Drug name stem
- -fos-; -vir
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
Mechanisms of action
- Mechanism
- RNA-directed RNA polymerase inhibitor
- Action type
- Inhibitor
- Target
- RNA-directed RNA polymerase
- Protein identifier
- O39930
Open Targets mechanisms
- Mechanism
- RNA-directed RNA polymerase inhibitor
- Action type
- Inhibitor
- Target
- RNA-directed RNA polymerase
- Action type
- Inhibitor
- Protein identifier
- P27958
- Organism
- Hepatitis C virus genotype 1a (isolate H)
- Action type
- Inhibitor
- Gene symbol
- NS5B
- Protein identifier
- Q8JXU8
- Organism
- Hepatitis C virus
- Condition
- Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Virus Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000763
- Subject identifier
- D014777
- Condition
- Hepatitis C
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003047
- Subject identifier
- D006526
- Condition
- Hepatitis B, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004197
- Subject identifier
- D019694
- Condition
- Hepatitis C, Chronic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004220
- Subject identifier
- D019698
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0100096
- Subject identifier
- D045169
- Condition identifier
- EFO_0000180
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000763
- Condition identifier
- EFO_0003047
- Condition identifier
- EFO_0004197
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004220
- Condition identifier
- EFO_0008496
- Condition identifier
- EFO_0009909
- Highest recorded phase
- 2
- Condition identifier
- EFO_0010721
- Highest recorded phase
- 1
- Condition identifier
- HP_0000739
- Condition identifier
- HP_0000855
- Condition identifier
- HP_0001394
- Highest recorded phase
- 3
- Condition identifier
- HP_0001395
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0000432
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002050
- Condition identifier
- MONDO_0004967
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005062
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005108
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005109
- Condition identifier
- MONDO_0005154
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005155
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005231
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005300
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005344
- Highest recorded phase
- 3
And 13 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
Open Targets warnings
- Warning
- Black Box Warning
- Country
- United States
- Event
- ascites
- Reports
- 435
- Reporting signal score
- 494.445
- Event
- drug hypersensitivity
- Reports
- 28
- Reporting signal score
- 397.753
- Event
- fatigue
- Reports
- 5,835
- Reporting signal score
- 5,323.13
- Event
- genotype drug resistance test positive
- Reports
- 363
- Reporting signal score
- 1,234.01
- Event
- headache
- Reports
- 4,869
- Reporting signal score
- 4,418.11
- Event
- hepatic cancer
- Reports
- 173
- Reporting signal score
- 380.306
- Event
- hepatic cirrhosis
- Reports
- 298
- Reporting signal score
- 404.454
- Event
- hepatic encephalopathy
- Reports
- 284
- Reporting signal score
- 474.351
- Event
- hepatic failure
- Reports
- 388
- Reporting signal score
- 542.42
- Event
- hepatitis c
- Reports
- 2,390
- Reporting signal score
- 7,816.11
- Event
- hepatitis c virus test positive
- Reports
- 115
- Reporting signal score
- 378.217
- Event
- hepatocellular carcinoma
- Reports
- 1,041
- Reporting signal score
- 3,157.22
- Event
- injection site pain
- Reports
- 4
- Reporting signal score
- 376.526
- Event
- insomnia
- Reports
- 1,287
- Reporting signal score
- 781.737
- Event
- treatment failure
- Reports
- 1,057
- Reporting signal score
- 1,142.97
- NCT01054729
- NCT01188772
- NCT01441180
- NCT01466790
- NCT01497327
- NCT01497366
- NCT01532908
- NCT01910636
- NCT02032875
- NCT02032888
- NCT02032901
- NCT02064049
- NCT02102451
- NCT02114151
- NCT02114177
- NCT02128542
- NCT02133131
- NCT02156570
- NCT02165189
- NCT02175966
- NCT02214420
- NCT02278419
- NCT02319031
- NCT02336139
- NCT02347345
And 98 more, listed on the interactive page.
- Dose
- 400 mg
- Route
- Oral
- How often
- Once daily
Conditions of use
- Take with food
- Hydrogen bond acceptors
- 10
- Hydrogen bond donors
- 3
- Polar surface area
- 158.18
- Calculated partition coefficient (ALogP)
- 1.66
- Calculated partition coefficient (XLogP)
- 1
- Prodrug
- Yes
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 1
- Rotatable bonds
- 10
- Heavy atoms
- 36
- Molecular formula
- C22H29FN3O9P
- Monoisotopic mass
- 529.16254467
- Natural product
- No
- 61958-1501
- 61958-1503
- 61958-1504
- 61958-1505
- 61958-1801
- 61958-1803
- 61958-1804
- 61958-1805
- 61958-2201
- 61958-2203
- 61958-2204
- 61958-2205
- 61958-2401
- 72626-2601
- 72626-2701
- Recorded assays
- 414
- Active assays
- 96
Active assay types
- Confirmatory
- Antiviral Agents
These details could not be displayed.
Related records
Trials (399)
- 12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF
- 8- Versus 12-week of Sofosbuvir-ravidasvir Treatment of Chronic Hepatitis C
- A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION.
- A Bio-equivalence Study of Sofosbuvir From Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharma, Egypt) & Sovaldi 400 mg Film Coated Tablets (Gilead Sciences, United Kingdom)
- A Bio-equivalence Study of Sofosbuvir From Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
- A Bio-equivalence Study of Sofosbuvir From Sofodelevier 400 mg Film Coated Tablets (Al-debeiky Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
- A Clinical Study Comparing Safety and Immunogenicity of bOPV of Bilthoven Biologicals
- A Clinical Trial of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotypes 1,4 Who Have Failed to Treat With a Regime Based on an Inhibitor of the NS5A
- A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study
- A Dose Escalation Study of Duvortuxizumab in Participants With Relapsed or Refractory B-cell Malignancies
- A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients.
- A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
- A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C
- A Phase 1 Study to Assess the Safety and Effects of Single and Multiple Doses of KS101 in Healthy Volunteers
- A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)
- A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
- A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
- A Phase I Study to Evaluate the Taste of Belumosudil Oral Suspensions & Assess Relative Bioavailability
- A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma (HCC), Melanoma, and Pediatric Cancer
- A Phase II Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use
Approved for (3)
- Chronic hepatitis C virus infection
- Hepatitis C virus infection
- Viral infectious disease
In development for (4)
- COVID-19 Phase 3
- Hepatitis B virus infection Phase 2
- Lymphoma Phase 2
- Severe acute respiratory syndrome Phase 3