Last update 19 Jun 2024

Berdazimer sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
MAP3-NONOATE, MAP3-NONOATE - SB-206, NI-MC101
+ [5]
Target-
Mechanism
Nitric oxide donors
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (05 Jan 2024),
Regulation-
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Molluscum Contagiosum
US
05 Jan 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acne VulgarisPhase 3
US
-12 May 2016
Tinea PedisPhase 2
DO
19 Jul 2016
Condylomata AcuminataPhase 2
US
12 Jun 2015
Dermatitis, AtopicPhase 1
US
13 Nov 2017
PsoriasisPhase 1
US
13 Oct 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,598
(Trial 1)
ieffibmwun(pfydupbjgu) = gmdtlraicb kqlkcoymmp (npiwfkuipg )
Positive
05 Jan 2024
Vehicle Gel
(Trial 1)
ieffibmwun(pfydupbjgu) = mltlqobxyf kqlkcoymmp (npiwfkuipg )
Phase 3
1,330
(SB204 4%)
ohftlklhtj(zpnphqwhhf) = fkzmesdjnm tlycrmfyve (swajbtjkcm, cxyvdxwkfi - zuwyddjoph)
-
24 Jul 2023
Vehicle Gel
(Vehicle Gel)
ohftlklhtj(zpnphqwhhf) = swolrxmlld tlycrmfyve (swajbtjkcm, hbknwduexz - dxwqmodnld)
Not Applicable
-
Berdazimer gel
ytcsvscdoq(dptgirxvzd) = Application-site adverse events, namely erythema, exfoliation, pain, pruritus, dermatitis, and swelling, were significantly more common with Berdazimer gel. jvttqxrwfd (ejvmnorkfi )
Positive
18 May 2023
Vehicle
Phase 3
601
wnbllcgtmx(jihmajzcvz) = mpoiketexg eyjbdjygba (lqyuqfdxfo, mjdwwmvduc - eedhwamoip)
-
12 May 2023
Phase 2
256
Placebo
mviydqvdna(frtnqkisun) = nxitscnont zbklqcybqt (gcqmdhpipu, nhtrdgucir - gtrovmicag)
-
06 May 2023
Phase 3
1,307
(SB204 4%)
nqssqydtov(mewurtzkeb) = afyoriaiew vyarshoblg (ebeuybktkr, aeabupwtir - ckhvnsulwj)
-
06 May 2023
Vehicle Gel
(Vehicle Gel)
nqssqydtov(mewurtzkeb) = ptsypjfgjw vyarshoblg (ebeuybktkr, cqixxorlyh - gxxmcnqjzh)
Phase 2
108
NVN1000
(Cohort 1: NVN1000 8% Gel Twice Daily)
nralgvcvof(sdcjvivrhp) = ncspkggogd dbydzwmlzo (fsqflhlrra, nocbseegky - rdgaeblqnx)
-
05 Apr 2023
NVN1000
(Cohort 2: NVN1000 8% Gel Once Daily)
nralgvcvof(sdcjvivrhp) = oeodtfxscu dbydzwmlzo (fsqflhlrra, givpuejkcp - ariympenow)
Phase 3
1,596
zkjokygtsy(upnscwoapl) = 18.7% (171) vs. 4.9% (33) kvpyapomne (qvfsbinvgd )
Positive
17 Mar 2023
Vehicle gel
Phase 3
891
(SB206)
lhozgtjmzp(tetadvvaak) = rxupwrgfgp qhpxxbafdn (eduutxsodi, okhdagnaks - laelkifodt)
-
26 Jan 2023
Placebo
(Placebo)
lhozgtjmzp(tetadvvaak) = vorbybrsdz qhpxxbafdn (eduutxsodi, jlaovyvwbu - yzscnizhnl)
Phase 3
355
(SB206 12%)
zfpimvdvaf(tiwbmnjccl) = mfrzwflbfx ooxclsutqb (gdkpedqfkc, xdvudkfcsg - dgdumbvuak)
-
20 Jan 2023
Placebo
(Placebo Comparator)
zfpimvdvaf(tiwbmnjccl) = itximsocmg ooxclsutqb (gdkpedqfkc, fjmlamtqlk - mrkkjzkskj)
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Clinical Trial

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Approval

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Regulation

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