PEGASYS (peginterferon alfa-2a) · Pharmaand GmbH
PEGASYS is an interferon alpha indicated for the treatment of chronic hepatitis C (CHC) and chronic hepatitis B (CHB) in adult and pediatric patients with compensated liver disease. In adults with CHC, it is typically administered as part of a combination regimen with other antiviral drugs, though it may be used as monotherapy if other treatments are contraindicated. For CHB, the drug is used in adults with viral replication and liver inflammation, and in non-cirrhotic pediatric patients aged three and older. It is not recommended for patients who have previously failed interferon-alfa therapy or those who have received solid organ transplants.
How PEGASYS Works
PEGASYS is a pegylated recombinant human interferon alfa-2a that functions as an inducer of the innate antiviral immune response. As an interferon alpha, the drug activates the body's natural defenses to produce an antiviral effect. This induction of the immune system is utilized to treat chronic viral infections of the liver by addressing viral replication and inflammation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2002-10-16
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SYRINGE, VIAL
PEGASYS Approval History
What PEGASYS Treats
2 indicationsPEGASYS is approved for 2 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Hepatitis C
- Chronic Hepatitis B
PEGASYS Boxed Warning
RISK OF SERIOUS DISORDERS WARNING: RISK OF SERIOUS DISORDERS See full prescribing information for complete boxed warning. Risk of Serious Disorders May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders ( 5 ) Risk of Serious Disorders Alpha interferons, including PEGASYS (peginterferon alfa-2a), may cause or aggravate fata...
WARNING: RISK OF SERIOUS DISORDERS WARNING: RISK OF SERIOUS DISORDERS See full prescribing information for complete boxed warning. Risk of Serious Disorders May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders ( 5 ) Risk of Serious Disorders Alpha interferons, including PEGASYS (peginterferon alfa-2a), may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy [see Warnings and Precautions (5.2 , 5.5 , 5.8 , 5.11 , 5.14 , 5.16) , Adverse Reactions (6.1) and Nonclinical Toxicology (13.1) ] .
PEGASYS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PEGASYS
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
70 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01718301 BOC-HIV results posted | BOC-HIV 2012-003984-23 | Ph 3 | terminated | HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin |
| NCT02992704 INACTIVE | 2014/00205 | Ph 2, Ph 3 | completed | Peg-interferon for Inactive Chronic Hepatitis B Carriers |
| NCT06922643 results posted | NNG00 | Ph 4 | completed | Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital |
| NCT01194037 | HL-143IFN-SC-US-001 | Ph 1, Ph 2 | completed | A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C |
| NCT06144697 | CN009-1024 | Ph 1 | terminated | A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants |
| NCT02430181 LOWR-1 results posted | EIG-300 Application #1128309 | Ph 2 | completed | Lonafarnib With and Without Ritonavir in HDV (LOWR-1) |
| NCT01387763 DALIAH | daliah2011 | Ph 3 | completed | A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms |
| NCT05129644 | A09-102 | Ph 1 | completed | Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects |
| NCT03294798 | 9216-Ib | Ph 1, Ph 2 | completed | Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient |
| NCT00758043 results posted | VX08-950-111 EudraCT 2008-003836-39 | Ph 3 | completed | A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response |
| NCT03020082 results posted | ASC08201503 | Ph 3 | completed | Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III |
| NCT01373684 PAS | HBV11-01 | Ph 4 | completed | PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients |
| NCT02407080 | GCO 12-0481-1001 MPD-RC 115, GCO 14-1919 | Ph 1 | completed | Open Label Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia |
| NCT02565719 | REP 401 | Ph 2 | completed | REP 2139-Mg and REP 2165-Mg Combination Therapy in Chronic Hepatitis B Infection |
| NCT02364336 results posted | 150082 15-DK-0082 | Ph 2 | completed | Add-on Peginterferon Following Nucleos(t)Ide Analogue Treatment |
| NCT01598090 PEDESTAL results posted | AI452-020 2011-004695-11 | Ph 3 | completed | Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir |
| NCT01259856 results posted | GCO 09-1300-00002 P01CA108671, MPD-RC 112 | Ph 3 | completed | Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) |
| NCT02908191 | ABI-H0731-101 | Ph 1 | completed | A Study in Healthy Volunteers and Patients With Chronic Hepatitis B |
| NCT02601976 EUROP results posted | GETZ-UNIP- 4010810 | Ph 4 | completed | Evaluation of Unipeg® for Response and Ongoing Safety in Pakistani Population |
| NCT03020004 results posted | ASC08201502 | Ph 2 | completed | Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II |
| NCT01758588 results posted | 1202012178 | Ph 2 | terminated | Pegylated Interferon Alpha-2b in Early Primary Myelofibrosis |
| NCT01889433 | BCD-016-3 | Ph 3 | completed | An Open-label Comparative Efficacy and Safety Study of Algeron (Cepeginterferon Alfa-2b) in Treatment-naive Patients With Chronic Hepatitis C |
| NCT03109730 | ABI-H0731-101B | Ph 1, Ph 2 | completed | Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B |
| NCT02097004 E+VIP | E+VIP | Ph 4 | completed | Study of Therapeutic Vaccination With Intensified Schedule Plus Pegasys Dual Therapy on Chronic Hepatitis B Infection |
| NCT02401737 | NVR3-778-101B | Ph 1 | completed | Dose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients |
| NCT02112799 | NVR3-778-101 | Ph 1 | completed | Safety and Efficacy Study of NVR 3-778 in Healthy Volunteers and Hepatitis B Patients |
| NCT03125213 | AL-3778-1003 | Ph 2 | withdrawn | A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects |
| NCT01265511 results posted | SCY-635-201 | Ph 2 | completed | Study of SCY-635, Pegasys and Copegus in Hepatitis C |
| NCT01415141 | M11-219 | Ph 4 | withdrawn | Peginterferon and Ribavirin, With or Without Telaprevir, for Genotype 1 Hepatitis C and IL28B CC Polymorphism |
| NCT01890200 | TCM-700-02-01 | Ph 3 | withdrawn | The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III) |
| NCT01482390 | NV27779 2011-002715-28 | Ph 2 | completed | A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C |
| NCT00845065 results posted | P05685 | Ph 3 | completed | Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05685AM2)(COMPLETED) |
| NCT01446250 results posted | CDEB025A2307 | Ph 3 | terminated | Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1 |
| NCT01259817 | GCO 09-1300 001 P01CA108671, MPD-RC 111 | Ph 2 | completed | Pegylated Interferon Alfa-2a Salvage Therapy in High Risk Polycythemia Vera (PV) or Essential Thrombocythemia (ET) |
| NCT01331850 | WV21913 2010-019585-90 | Ph 2 | completed | A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C |
| NCT01220947 | NV22776 2010-019584-10 | Ph 2 | completed | A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection |
| NCT00963885 | NV21075 2009-009608-38 | Ph 2 | completed | A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection |
| NCT01318694 results posted | CDEB025A2301 2010-022867-37 | Ph 3 | completed | Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants |
| NCT01215643 results posted | CDEB025A2211 2010-020034-26 | Ph 2 | completed | Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants |
| NCT01183169 results posted | CDEB025A2210 2010-020033-14 | Ph 2 | completed | Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment |
| NCT01482403 | NV27780 2011-002714-37 | Ph 2 | completed | A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C |
| NCT01500772 results posted | CDEB025A2306 2011-004653-31 | Ph 3 | terminated | Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C |
| NCT01447420 results posted | ML25592 | Ph 4 | completed | A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) |
| NCT01592006 results posted | 12-0156 | Ph 4 | terminated | Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients |
| NCT01492426 COMMAND-3 results posted | AI444-052 2011-004237-14 | Ph 3 | completed | Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection |
| NCT00560274 | ML21362 | Ph 4 | completed | A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C. |
| NCT02646189 | REP 102 | Ph 1, Ph 2 | completed | Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients |
| NCT01170962 HEPCAT results posted | AI444-011 2010-019378-34 | Ph 2 | completed | Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment |
| NCT01030432 | AI447-016 2009-013652-69 | Ph 2 | completed | Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin |
| NCT01718158 STRUCTURE | AI452-021 2011-005409-65 | Ph 3 | completed | Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy |
Showing 50 of 70 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PEGASYS FDA Label Details
Indications & Usage
FDA Label (PDF)PEGASYS is an inducer of the innate immune response indicated for the treatment of Chronic Hepatitis C (CHC) Adult Patients: In combination therapy with other hepatitis C virus drugs for adults with compensated liver disease. PEGASYS monotherapy is indicated only if patient has contraindication or significant intolerance to other HCV drugs. Pediatric Patients: In combination with ribavirin for pediatric patients 5 years of age and older with compensated liver disease Chronic Hepatitis B (CHB) Adult Patients: Treatment of adults with HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB) i...
WARNING: RISK OF SERIOUS DISORDERS WARNING: RISK OF SERIOUS DISORDERS See full prescribing information for complete boxed warning. Risk of Serious Disorders May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment