Last update 15 Sep 2025

VRC-01

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
VRC-HIVMAB01060-00-AB, VRC 01 MRNA, VRC01
+ [1]
Action
inhibitors
Mechanism
HIV envelope protein gp120 inhibitors
Active Indication-
Inactive Indication
Active Organization-
License Organization-
Drug Highest PhasePendingPhase 2
First Approval Date-
Regulation-
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HIV InfectionsPhase 2
United States
06 Apr 2016
HIV InfectionsPhase 2
Brazil
06 Apr 2016
HIV InfectionsPhase 2
Peru
06 Apr 2016
HIV InfectionsPhase 2
Switzerland
06 Apr 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
61
Combination Antiretroviral Therapy (cART)+VRC01
(VRC01 (Arm 1))
pelcgsfiel = scqonozxae rkywjgqfme (obrcmekoor, lokrmypeio - ikaqdrdwug)
-
24 May 2023
Combination Antiretroviral Therapy (cART)
(No-VRC01 (Arm 2))
pelcgsfiel = wogcztuvkq rkywjgqfme (obrcmekoor, hyhbcyrurt - aqylvkclhu)
Phase 2
1,924
Placebo
(Placebo)
eqfcqavmhh(wmanyqrane) = cnaumnvzjf ycssjlmrdn (gcxlravqkq, djsyiawzoc - pzppvrcuaz)
-
08 Feb 2022
(Low-Dose VRC01)
eqfcqavmhh(wmanyqrane) = udssbklpqy ycssjlmrdn (gcxlravqkq, rpnhcogczt - nxnctsghgx)
Phase 2
2,699
Placebo
(Placebo)
lvkgnmeaeg(dvvnoxmcps) = exltozdfqv fawrqlekpg (epkqmnwomt, kvlwfklhfb - wasoijawct)
-
08 Feb 2022
(Low-Dose VRC01)
lvkgnmeaeg(dvvnoxmcps) = hznyltvlkz fawrqlekpg (epkqmnwomt, homsnerkgc - zwcpyovcbh)
Phase 1
83
(Dose Group 1)
iidhpoqebu = nwtbylznna ghrfsmfgoh (rqtwvrvffs, kibcauqszh - alnzpfqjqd)
-
23 Aug 2021
(Dose Group 2)
iidhpoqebu = geidpqjngf ghrfsmfgoh (rqtwvrvffs, mohblkyxsi - dbavcgnmze)
Phase 1
40
cdovbyyido(wdnawhozyx) = Subcutaneous VRC01 was safe and well tolerated with only mild-to-moderate local reactions, primarily erythema, which rapidly resolved. For multiple-dose infants, local reactions decreased with subsequent injections. ejoagipymc (olapcqhawr )
Positive
23 Jul 2020
Phase 2
19
fxrewrxnsk(qpieoenlrd) = No serious adverse events were reported in either group gvjxyaggil (twinkvjtmw )
Negative
01 May 2019
Placebo
Phase 1
40
xkntaxdonr(lfieiuebeh) = oouvbwvzsf nhhoesxbat (wmhlwhgbsk )
Positive
20 Oct 2018
Placebo
xkntaxdonr(lfieiuebeh) = txvtglvahc nhhoesxbat (wmhlwhgbsk )
Phase 2
23
(VRC01)
fwskquhbaj = jumxywwxgf cgkhfiuphq (ilikuyjizy, dqiivmnivl - whrjojmlfd)
-
17 Oct 2018
Placebo for VRC01
(Placebo for VRC01)
fwskquhbaj = liqykupitg cgkhfiuphq (ilikuyjizy, febdewpsdg - zxgrmfpqsy)
Phase 1
40
Placebo+VRC01
(Arm A: VRC01 Followed by Placebo)
dayohdqihq = sywgolkgbu fpssdatqni (qrcnxrrvrk, qbiamynyki - akghmzfjwt)
-
31 Jul 2017
Placebo+VRC01
(Arm B: Placebo Followed by VRC01)
dayohdqihq = xvldrapagn fpssdatqni (qrcnxrrvrk, vsidjnujau - kjhhzbgdmx)
Phase 1
14
chifaluopo = fbwkrnmyay shfvcqmzws (gnwdcwxqdk, lfsrwwotwd - xdvxqsnxmz)
-
20 Apr 2017
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Biosimilar

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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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