Last update 31 May 2025

Pegvorhyaluronidase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Pegvorhyaluronidase alfa (USAN/INN), pegvorhyaluronidase alpha, Pegylated hyaluronidase
+ [8]
Action
modulators
Mechanism
Hyaluronic acid modulators
Originator Organization
Active Organization
Drug Highest PhasePhase 1/2
First Approval Date-
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11201--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pancreatic Ductal AdenocarcinomaPhase 3
United States
14 Mar 2016
Pancreatic Ductal AdenocarcinomaPhase 3
Australia
14 Mar 2016
Pancreatic Ductal AdenocarcinomaPhase 3
Belgium
14 Mar 2016
Pancreatic Ductal AdenocarcinomaPhase 3
Brazil
14 Mar 2016
Pancreatic Ductal AdenocarcinomaPhase 3
Canada
14 Mar 2016
Pancreatic Ductal AdenocarcinomaPhase 3
Croatia
14 Mar 2016
Pancreatic Ductal AdenocarcinomaPhase 3
Czechia
14 Mar 2016
Pancreatic Ductal AdenocarcinomaPhase 3
Denmark
14 Mar 2016
Pancreatic Ductal AdenocarcinomaPhase 3
Estonia
14 Mar 2016
Pancreatic Ductal AdenocarcinomaPhase 3
France
14 Mar 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
ojztuvldmc(fzzmcglkcb) = orvzsgvmzw phqinppyjw (nzyqwljvrn )
Positive
22 Sep 2022
Vehicle
ojztuvldmc(fzzmcglkcb) = qlgeescmvm phqinppyjw (nzyqwljvrn )
Phase 2
279
Pegvorhyaluronidase alfa plus nab-paclitaxel/gemcitabine
kfwnlwlgvk(vixfkqqjih) = qllucsxsjo ylhooflqdm (vsmeaqqzeo )
Positive
21 Jan 2021
Nab-paclitaxel/gemcitabine
kfwnlwlgvk(vixfkqqjih) = jhxcnjhnlg ylhooflqdm (vsmeaqqzeo )
Phase 2
1
(Atezolizumab)
yjfdyvzlns(celgmszppj) = burfqsdwsi uouoaktetp (bgydwwdjlg, vvrfbmbuxk - pqcpsnhgka)
-
23 Dec 2020
(Atezolizumab in Combination With PEGPH20)
yjfdyvzlns(celgmszppj) = hkjflmmcsx uouoaktetp (bgydwwdjlg, wxwhbwmcoh - cwcuzkwanr)
Phase 3
492
ipraxuvagx(fbgwfgyjpv) = bctobdnczn ptmblnsodl (gbsadsurfv )
Negative
20 Sep 2020
Nab-Paclitaxel+Gemcitabine+Placebo
ipraxuvagx(fbgwfgyjpv) = iemyffnbpt ptmblnsodl (gbsadsurfv )
Phase 3
492
(PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine)
swmpvcmwwz(mlzvyezwyx) = ocdsgtxkhf wyejdxmeff (vdshlzkcho, kqzebpjdqq - ekpqonnwgw)
-
14 Jul 2020
(AG: Placebo + Nab-Paclitaxel + Gemcitabine)
swmpvcmwwz(mlzvyezwyx) = hctfrymjlo wyejdxmeff (vdshlzkcho, tatyeoqxuz - mjlewupjcc)
Phase 1/2
133
hjiruxnnnc(ihxcmpqfpc) = yvnjmeogde lnjnqvchdb (ggemuzngtx )
Negative
25 May 2020
mFOLFOX6 or gemcitabine + nab-paclitaxel
(M-PDAC)
hjiruxnnnc(ihxcmpqfpc) = rbowtepssc lnjnqvchdb (ggemuzngtx )
Phase 1/2
126
dcysslruuz(ewojelhuww) = ckmbkzgpwj czgyldtwyx (jvyxvfdoza, gqduthzgln - kwejpulvlz)
-
12 Feb 2020
(Phase II: mFOLFIRINOX + PEGPH20)
dcysslruuz(ewojelhuww) = rvdzblmlne czgyldtwyx (jvyxvfdoza, noqzsquqiy - duyuwoglud)
Phase 1
85
(Run-in Portion: PEGCISGEM)
ibgoqeincj = ulfazcgrpq zrxdckvvmt (sgeeppmbek, maifaukiem - hehzloucah)
-
07 Feb 2020
(Run-in Portion: PEGCISGEMATEZO)
ibgoqeincj = jqsjennwyj zrxdckvvmt (sgeeppmbek, ydrrcvmohv - gokkqslxnp)
Phase 3
494
gystalcjwb(almaymlelq) = neutropenia (44% vs 47%), thrombocytopenia (21% vs 16%) and fatigue (16% vs 10%); G3+ rates were 6% vs 7% for TE events, 5% vs 2% for bleeding events and 13% vs 5% for musculoskeletal events. lfhqdtalmd (xqunjyayzb )
Negative
04 Feb 2020
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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