Peginterferon alfa-2A
Highest phase reached
Approved
Drug type
Protein
First approval year
2002
- First approval year
- 2002
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Peginterferon alfa-2A
- pegasys
- Pegasys
- peginterferon alfa 2a component of peginterferon
- Peginterferon alfa-2a component of peginterferon
- entecavir and peginterferon pegasys 52 weeks
- INTERFERON .ALPHA.A (HUMAN LEUKOCYTE), MONO(N(SUP 2),N(SUP 6)-DICARBOXYL-L-LYSYL) DERIVATIVE, DIESTER WITH POLYETHYLENE GLYCOL MONOMETHYL ETHER
- INTERFERON .ALPHA.A (HUMAN LEUKOCYTE), MONO(N(SUP 2),N(SUP6)-DICARBOXYL-L-LYSYL) DERIVATIVE, DIESTER WITH .ALPHA.-METHYL-.OMEGA.-HYDROXYPOLY(OXY-1,2-ETHANEDIYL)
- interferon alpha a human leukocyte mono n sup 2 n sup 6 dicarboxyl l lysyl derivative diester with polyethylene glycol monomethyl ether
- interferon alpha a human leukocyte mono n sup 2 n sup6 dicarboxyl l lysyl derivative diester with alpha methyl omega hydroxypoly oxy 1 2 ethanediyl
- peg interferon alfa 2a
- Peg-interferon alfa 2a
- PEG-Interferon alfa 2a
- peg-interferon alfa-2a
- peg-Interferon alfa-2a
- Peg-interferon alfa-2a
- Peg-interferon Alfa-2a
- Peg-Interferon Alfa-2a
- PEG-interferon alfa-2a
- PEG-interferon-Alfa-2A
- Peg-interferon-alfa2a (Pegasys)
- PEG-Interferon-alpha 2a (Pegasys®)
- Pegasys
- PEGASYS
- PEGASYS (peginterferon alfa-2a)
- PEGASYS [peginterferon alfa-2a]
- PEGASYS 180μg (Interféron pégylé alpha -2a)
- Pegasys®
- PEGASYS™
- Peginterferon .alpha.-2a
And 91 more, listed on the interactive page.
- CAS registry numbers
- 198153-51-4
- ChEMBL ID
- CHEMBL1201560
- RxNorm IDs (RxCUI)
- 120608
- FDA ingredient codes (UNII)
- Q46947FE7K
- L03AB11
- L03AB61
Sources for recorded values
- Applicant
- Pharmaand GmbH
- Approval date
- 16 Oct 2002
- Application number
- BLA103964
- Status
- Authorised
- Status date
- 20 Jun 2002
- Authorisation date
- 20 Jun 2002
- Approved indications
- Polycythaemia veraPegasys is indicated as monotherapy in adults for the treatment of polycythaemia vera. Essential thrombocythaemiaPegasys is indicated as monotherapy in adults for the treatment of essential thrombocythaemia..Chronic hepatitis BAdult patientsPegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (ALT) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1).Paediatric patients 3 years of age and olderPegasys is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels. With respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1.Chronic hepatitis CAdult patientsPegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis C (CHC) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.2 and 5.1.Paediatric patients 5 years of age and olderPegasys in combination with ribavirin is indicated for the treatment of CHC in treatment-naïve children and adolescents 5 years of age and older who are positive for serum HCV-RNA.When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).
- Product number
- EMEA/H/C/000395
- Authorisation holder
- pharmaand GmbH
- 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
- No
- Exceptional circumstances
- No
Therapeutic areas
- Hepatitis B, Chronic
- Hepatitis C, Chronic
- Polycythemia Vera
- Thrombocythemia, Essential
European medicines record
- Patents
- 0
- Designations
- 2
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Drug name stem
- peg-
Administration routes
- Parenteral
- Mechanism
- Interferon alpha/beta receptor agonist
- Action type
- Agonist
- Target
- Interferon alpha/beta receptor
- Protein identifier
- P17181
- Mechanism
- Interferon alpha/beta receptor agonist
- Action type
- Agonist
- Target
- Interferon alpha/beta receptor
- Protein identifier
- P48551
Open Targets mechanisms
- Mechanism
- Interferon alpha/beta receptor agonist
- Action type
- Agonist
- Target
- Interferon alpha/beta receptor
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000339
- Subject identifier
- D015464
- Condition
- Thrombocythemia, Essential
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000479
- Subject identifier
- D013920
- Condition
- Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Melanoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- HIV Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Liver Cirrhosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001422
- Subject identifier
- D008103
- Condition
- Polycythemia Vera
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002429
- Subject identifier
- D011087
- Condition
- Primary Myelofibrosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002430
- Subject identifier
- D055728
- Condition
- Hepatitis C
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003047
- Subject identifier
- D006526
- Condition
- Kidney Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003086
- Subject identifier
- D007674
- Condition
- Hepatitis B
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004197
- Subject identifier
- D006509
- Condition
- Hepatitis B, Chronic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004197
- Subject identifier
- D019694
- Condition
- Hepatitis C, Chronic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004220
- Subject identifier
- D019698
- Condition
- Hepatitis B, Chronic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004239
- Subject identifier
- D019694
- Condition
- Hepatitis D
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007304
- Subject identifier
- D003699
- Condition
- Hepatitis, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0008496
- Subject identifier
- D006521
- Condition
- Diffuse Intrinsic Pontine Glioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000026
- Subject identifier
- D000080443
- Condition
- Clostridium Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000874
- Subject identifier
- D003015
- Condition
- Thrombocytopenia
- Highest recorded phase
- 2
- Condition identifier
- HP:0001873
- Subject identifier
- D013921
- Condition
- Hepatitis
- Highest recorded phase
- 3
- Condition identifier
- HP:0012115
- Subject identifier
- D006505
- Condition
- Depressive Disorder
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0002050
- Subject identifier
- D003866
And 5 more, listed on the interactive page.
- Condition identifier
- EFO_0000339
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000479
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000764
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000768
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001422
- Highest recorded phase
- 3
- Condition identifier
- EFO_0002429
- Condition identifier
- EFO_0003047
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003086
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004197
- Condition identifier
- EFO_0004220
- Condition identifier
- EFO_0004239
- Condition identifier
- EFO_0007304
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000026
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001927
- Highest recorded phase
- 1
- Condition identifier
- HP_0000155
- Highest recorded phase
- 2
- Condition identifier
- HP_0000855
- Highest recorded phase
- 2
- Condition identifier
- HP_0001394
- Highest recorded phase
- 3
- Condition identifier
- HP_0001395
- Highest recorded phase
- 3
- Condition identifier
- HP_0001873
- Highest recorded phase
- 2
- Condition identifier
- HP_0003510
- Highest recorded phase
- 2
And 73 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
Open Targets warnings
- Warning
- Black Box Warning
- Country
- United States
- Event
- anaemia
- Reports
- 3,638
- Reporting signal score
- 5,463.71
- Event
- anal pruritus
- Reports
- 111
- Reporting signal score
- 336.647
- Event
- anorectal discomfort
- Reports
- 125
- Reporting signal score
- 304.382
- Event
- ascites
- Reports
- 219
- Reporting signal score
- 231
- Event
- asthenia
- Reports
- 1,161
- Reporting signal score
- 386.258
- Event
- decreased appetite
- Reports
- 913
- Reporting signal score
- 544.86
- Event
- depression
- Reports
- 1,181
- Reporting signal score
- 898.818
- Event
- dysgeusia
- Reports
- 521
- Reporting signal score
- 552.966
- Event
- exposure via direct contact
- Reports
- 81
- Reporting signal score
- 310.376
- Event
- fatigue
- Reports
- 2,280
- Reporting signal score
- 806.445
- Event
- haemoglobin decreased
- Reports
- 1,171
- Reporting signal score
- 1,169.71
- Event
- hepatic cirrhosis
- Reports
- 262
- Reporting signal score
- 380.922
- Event
- hepatitis c
- Reports
- 586
- Reporting signal score
- 1,233.31
- Event
- influenza like illness
- Reports
- 653
- Reporting signal score
- 649.181
- Event
- insomnia
- Reports
- 811
- Reporting signal score
- 360.214
- Event
- leukopenia
- Reports
- 698
- Reporting signal score
- 730.996
- Event
- neutropenia
- Reports
- 1,065
- Reporting signal score
- 700.86
- Event
- neutrophil count decreased
- Reports
- 618
- Reporting signal score
- 777.273
- Event
- pancytopenia
- Reports
- 743
- Reporting signal score
- 845.748
- Event
- platelet count decreased
- Reports
- 1,223
- Reporting signal score
- 1,328.71
- Event
- pruritus
- Reports
- 1,133
- Reporting signal score
- 532.19
- Event
- pyrexia
- Reports
- 1,299
- Reporting signal score
- 402.096
- Event
- rash
- Reports
- 1,878
- Reporting signal score
- 894.059
- Event
- red blood cell count decreased
- Reports
- 384
- Reporting signal score
- 519.119
- Event
- retinopathy
- Reports
- 173
- Reporting signal score
- 373.607
And 4 more, listed on the interactive page.
- NCT00003542
- NCT00006164
- NCT00028093
- NCT00039962
- NCT00077636
- NCT00077649
- NCT00081770
- NCT00087568
- NCT00087594
- NCT00087607
- NCT00087633
- NCT00087646
- NCT00093093
- NCT00107653
- NCT00115908
- NCT00118768
- NCT00120861
- NCT00144469
- NCT00152581
- NCT00158496
- NCT00192647
- NCT00221624
- NCT00336479
- NCT00336518
- NCT00353418
And 320 more, listed on the interactive page.
- Dose
- 180 mcg
- Route
- Subcutaneous
- How often
- Once weekly
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Sequence
- Type
- Protein
- Sequence
- CDLPQTHSLGSRRTLMLLAQMRKISLFSCLKDRHDFGFPQEEFGNQFQKAETIPVLHEMIQQIFNLFSTKDSSAAWDETLLDKFYTELYQQLNDLEACVIQGVGVTETPLMKEDSILAVRKYFQRITLYLKEKKYSPCAWEVVRAEIMRSFSLSTNLQESLRSKE
- 82154-0449
- 82154-0451
Related records
Trials (504)
- 100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)
- 24 VS 48-WEEK TREATMENT WITH PEG-IFN ALPHA-2A IN PATIENTS WITH GENOTYPE 2/3 CHRONIC HEPATITIS C
- 4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C
- 48 Weeks Combination Therapy for Patients With HBeAg-negative Chronic Hepatitis B Virus (HBV) Infection
- A Clinical Trial of PEGIFNα1b in Chinese Healthy Adults
- A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon
- A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected With Both HIV and Hepatitis C Virus (HCV)
- A Follow-up Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
- A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
- A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
- A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection
- A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
- A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C
- A Phase II Study of Pegylated Interferon Alfa 2b (PEG-Intron(Trademark)) in Children With Diffuse Pontine Gliomas
- A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection
- A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy
- A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients
- A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
- A Pilot Trial to Determine the Safety and Efficacy of Fluvastatin in Previous Partial Responders to Pegylated Interferon and Ribivirin in Patients With Genotype 1 Hepatitis C
- A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels
Approved for (5)
- Cancer
- Chronic hepatitis B virus infection
- Chronic hepatitis C virus infection
- Hepatitis B virus infection
- Neoplasm
In development for (22)
- Acquired polycythemia vera Phase 3
- B-cell chronic lymphocytic leukemia Phase 1
- Breast cancer Phase 2
- Chronic myeloid leukemia Phase 3
- Cirrhosis of liver Phase 3
- Clostridium infectious disease Phase 2
- Depressive disorder Phase 3
- Diffuse intrinsic pontine glioma Phase 2
- Essential thrombocythemia Phase 3
- Hepatitis Phase 3
- Hepatitis C virus infection Phase 3
- Hepatitis D virus infection Phase 3
- Hepatocellular carcinoma Phase 2
- HIV infectious disease Phase 3
- Kidney cancer Phase 1
- Kidney disorder Phase 2
- Malignant colon neoplasm Phase 2
- Melanoma Phase 3
- Myelofibrosis Phase 3
- Plasma cell myeloma Phase 2