PharmaEssentia

PharmaEssentia

MA - Burlington
Biotechnology
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Focus: Biologics

PharmaEssentia is a life sciences company focused on Biologics.

HematologyOncologyInfectious DiseasesImmunology
Open Jobs
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Products & Portfolio (1)

BESREMI
ropeginterferon alfa-2b
Peak
SUBCUTANEOUS · INJECTABLE
interferons, which exhibit their cellular effects in polycythemia vera in the bone marrow by binding to a transmembrane receptor termed interferon alfa receptor (IFNAR). Binding to IFNAR initiates a downstream signaling cascade through the activation of kinases, in particular Janus kinase 1 (JAK1) and tyrosine kinase 2 (TYK2) and activator of transcription (STAT) proteins. Nuclear translocation of STAT proteins controls distinct gene-expression programs and exhibits various cellular effects. The actions involved in the therapeutic effects of interferon alfa in polycythemia vera are not fully elucidated.
2021
30

Pipeline & Clinical Trials

HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan
Solid Tumor Malignancy
N/A
Clinical Trials (1)
NCT06665776HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan
N/A
N/A
Clinical Trials (1)
NCT05494528Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy
N/A
ropeginterferon alfa-2b
Healthy Volunteers
Phase 1
Clinical Trials (1)
NCT03546465Safety, Tolerability, Pharmacokinetics & Pharmacodynamics Study of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects
Phase 1
P1101 + Ribavirin
Hepatitis C, Chronic
Phase 1
Clinical Trials (1)
NCT04774107The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection
Phase 1
KX01 0.01%
Psoriasis
Phase 1
Clinical Trials (1)
NCT05522816KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis
Phase 1
HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules
Solid Tumor
Phase 1
Clinical Trials (1)
NCT04035473A Study to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel
Phase 1
Phase 1
Clinical Trials (1)
NCT05129644Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects
Phase 1
Ropeginterferon alfa-2b
Cutaneous T Cell Lymphoma
Phase 1
Clinical Trials (1)
NCT07047885Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)
Phase 1
Phase 1
Clinical Trials (1)
NCT06698861A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers
Phase 1
Phase 1
Clinical Trials (1)
NCT03165955A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients
Phase 1
P1101 + Nivolumab + Entecavir
Chronic Hepatitis B Infection
Phase 1
Clinical Trials (1)
NCT04638439The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection
Phase 1
Sequential use of P1101 and P1801
Advanced Solid Tumors
Phase 1
Clinical Trials (1)
NCT07053904Phase I Open-Label Study of P1101 Followed by P1801 in Advanced Solid Tumors
Phase 1
Phase 1
Clinical Trials (1)
NCT04168957An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007
Phase 1
KX01 ointment 1%
Healthy Volunteer
Phase 1
Clinical Trials (1)
NCT05245578Safety Evaluation of KX01 Ointment 1% in Japanese Healthy Male Subjects
Phase 1
Phase 1/2
Clinical Trials (1)
NCT04233840P1101 and Anti-PD1 for After Curative Surgery of Hepatitis B-related Hepatocellular Carcinoma
Phase 1/2
Ropeginterferon alfa-2b
Polycythemia Vera
Phase 2
Clinical Trials (1)
NCT05485948A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU
Phase 2
Phase 2
Clinical Trials (1)
NCT04182100Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply
Phase 2
PEGASYS 180 µg Q1W
Hepatitis C, Chronic
Phase 2
Clinical Trials (1)
NCT01587586Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection
Phase 2
Ursodeoxycholic acid
Hepatitis D
Phase 2
Clinical Trials (1)
NCT05467553A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection
Phase 2
Phase 2
Clinical Trials (1)
NCT04180384A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients
Phase 2
Ropeginterferon alfa-2b-njft
Essential Thrombocythemia
Phase 2
Clinical Trials (1)
NCT05482971A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET
Phase 2
Peg-P-IFN-alpha-2b
Polycythemia Vera
Phase 3
Clinical Trials (1)
NCT01949805Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera
Phase 3
KX01 ointment 1%
Actinic Keratosis
Phase 3
Clinical Trials (1)
NCT05231044A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp
Phase 3
Ropeginterferon alfa-2b
Primary Myelofibrosis
Phase 3
Clinical Trials (1)
NCT06468033P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk
Phase 3
Pegylated-Proline-interferon alpha-2b
Polycythemia Vera
Phase 3
Clinical Trials (1)
NCT02218047AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.
Phase 3
Phase 3
Clinical Trials (1)
NCT04655092Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients
Phase 3
Phase 3
Clinical Trials (1)
NCT06002490A Study to Evaluate P1101 in Japanese PV Patients
Phase 3
Ropeginterferon alfa-2b
Essential Thrombocythemia
Phase 3
Clinical Trials (1)
NCT04285086Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance
Phase 3
Pegylated-Proline-Interferon alpha-2b in a Pre-filled Pen
Polycythemia Vera
Phase 3
Clinical Trials (1)
NCT02523638Study to Assess the Self-administration of AOP2014 Using a Pen, Developed for the Treatment of Polycythemia Vera Patients
Phase 3
Phase 3
Clinical Trials (1)
NCT04382937Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection
Phase 3
Phase 3
Clinical Trials (1)
NCT05481151A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV
Phase 3
Ropeginterferon alfa-2b
Polycythemia Vera
Phase 4
Clinical Trials (1)
NCT06290765Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera
Phase 4

Open Jobs (0)

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Interview Prep Quick Facts
Founded: 2003
Portfolio: 1 approved product, 32 clinical trials
Top TAs: Oncology
Portfolio Health
Peak1 (100%)
1 total products
Therapeutic Area Focus
Oncology
1 marketed
Marketed
Pipeline

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