> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/sofosbuvir-0299363f-7b98-4f5e-ad74-2373e14d1d7b
> Record changed: 2026-10-13

# Sofosbuvir

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1259059)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1259059)

First approval year

2013

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1259059)

## Development status

**First approval year**

2013

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1259059)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1259059)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1259059)

**Drug name**

Sofosbuvir

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1259059)

**Molecular weight**

529.46

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1259059)

**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

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1259059)

### Brand names (10)

- 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

### Other names (46)

- 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.

## Identifiers

**CAS registry numbers**

- 1190307-88-0

**ChEMBL ID**

CHEMBL1259059

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1259059)

**InChIKey**

TTZHDVOVKQGIBA-IQWMDFIBSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1259059)

**PubChem compound IDs**

- 45375808

**RxNorm IDs (RxCUI)**

- 1484911

**FDA ingredient codes (UNII)**

- WJ6CA3ZU8B

### ATC classification codes (2)

- J05AP08
- J05AX15

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1259059)

## Regulatory information

### United States

**Applicant**

GILEAD SCIENCES INC

**Approval date**

6 Dec 2013

**Application number**

NDA204671

### European Union

**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

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/sovaldi)

### Other regulatory facts

**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

### Drug classification

**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

### DrugCentral mechanisms (2)

- **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

### Investigated indications (8)

- **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

### Open Targets indications (38)

- **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

### Reported adverse events (15)

- **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

### Trial references (123)

- NCT01054729  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01054729)
- NCT01188772  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01188772)
- NCT01441180  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01441180)
- NCT01466790  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01466790)
- NCT01497327  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01497327)
- NCT01497366  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01497366)
- NCT01532908  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01532908)
- NCT01910636  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01910636)
- NCT02032875  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02032875)
- NCT02032888  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02032888)
- NCT02032901  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02032901)
- NCT02064049  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02064049)
- NCT02102451  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02102451)
- NCT02114151  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02114151)
- NCT02114177  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02114177)
- NCT02128542  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02128542)
- NCT02133131  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02133131)
- NCT02156570  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02156570)
- NCT02165189  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02165189)
- NCT02175966  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02175966)
- NCT02214420  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02214420)
- NCT02278419  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02278419)
- NCT02319031  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02319031)
- NCT02336139  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02336139)
- NCT02347345  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02347345)

And 98 more, listed on the interactive page.

## Dosing

**Dose**

400 mg

**Route**

Oral

**How often**

Once daily

### Conditions of use

- Take with food

## Chemical properties

**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

## National Drug Codes

- 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

## Evidence counts

**Recorded assays**

414

**Active assays**

96

### Active assay types

- Confirmatory

## Pharmacologic actions

- Antiviral Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000998.html)

## Biological measurements

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](https://trialight.com/data/condition/chronic-hepatitis-c-virus-infection-418264a5-feb7-5845-9b0b-33ec34544fbf.md)
- Hepatitis C virus infection
- [Viral infectious disease](https://trialight.com/data/condition/viral-infectious-disease-43db42a3-adad-5b9d-b74c-f17df0674c21.md)

### In development for (4)

- [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 3
- [Hepatitis B virus infection](https://trialight.com/data/condition/hepatitis-b-virus-infection-63cb6d13-50c4-5e97-86fd-ce5481d9d1c6.md) Phase 2
- [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) Phase 2
- [Severe acute respiratory syndrome](https://trialight.com/data/condition/severe-acute-respiratory-syndrome-7654d02a-f750-52a0-bec2-afe3b4b3c224.md) Phase 3

---

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