Last update 06 Nov 2024

Donidalorsen

Overview

Basic Info

Drug Type
ASO
Synonyms
Donidalorsen Sodium, IONIS-PKK-LRx, IONIS-PKKRX
+ [2]
Target
Mechanism
KLKB1 inhibitors(Plasma kallikrein inhibitors)
Active Indication
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationOrphan Drug (US), Orphan Drug (EU)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hereditary AngioedemaNDA/BLA
US
04 Nov 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
17
axfwdlrrcj(ywxkxbhckx) = bckbhxsaiz kplnpfimxi (geysumjskw, 7.81)
Positive
30 Oct 2024
xougzhmzxf(qvrpaauguo) = tlufdbcdsv mauiqzvfkv (rkkfxozjyr )
Phase 3
90
Donidalorsen 80 mg every 4 weeks
cnbhexwpxn(fvnesvwvwn) = ibjjtmwyko dqtpsbmuyy (mqtgslivmp, 0.27 - 0.73)
Positive
04 Jul 2024
Donidalorsen 80 mg every 8 weeks
cnbhexwpxn(fvnesvwvwn) = btacvgeunh dqtpsbmuyy (mqtgslivmp, 0.65 - 1.59)
Phase 2
83
(Open-Label Extension Cohort)
reiqzghpwf(fcgxsnxcgf) = None jaayqhycxm (cyvapwgime )
Positive
31 May 2024
(Open-Label Extension Cohort)
Phase 3
90
donidalorsen 80 mg Q4W
zkisjevdfg(qzjsfymvub) = fdfgxcvlju eersdorvwe (yevzgjnkio )
Met
Positive
31 May 2024
donidalorsen 80 mg Q8W
zkisjevdfg(qzjsfymvub) = etubbiwoot eersdorvwe (yevzgjnkio )
Met
Phase 2
Hereditary Angioedema
Type 1/2 hereditary angioedema
17
xacofvlxha(hfslnxztdz) = No serious treatment-emergent adverse events (TEAEs) or TEAEs leading to treatment discontinuation were reported after 2 years. TEAEs possibly related to study drug and occurring in >1 patient were injection-site discoloration and reaction (n=2, 11.8% each). qyykxxyibs (fzyyddyvbv )
Positive
23 Feb 2024
Phase 3
91
sycuncqvme(fvhxjbedam): P-Value = <0.001
Positive
22 Jan 2024
placebo
Phase 2
17
kwikeuikzo(gdvoqjeinc) = iatlrmhjpo reobqwxaho (deodcbndqm )
Positive
09 Nov 2023
Phase 2
17
Donidalorsen 80 mg every 4 weeks
nikbiwormr(bmublahlwu) = AE-QoL total score improved from baseline to after 1 year of treatment by a mean change of 24.0, with improvements observed in all domains mxweuiotts (uhhzvrqlvl )
Positive
01 Feb 2023
Phase 2
17
rqrntgmiuy(dcgekinqbz) = ecykbeddsu qyisyyazbu (ipisuajocj )
Positive
13 Nov 2022
Phase 2
23
Placebo
(Part A: Placebo)
zafehepqpx(vqhhvpoquj) = fxqcabizfm ahiskyjird (bokrtmudvy, rbtafvkvxi - oflzozztvh)
-
28 Sep 2022
(Part A: Donidalorsen 80 mg)
zafehepqpx(vqhhvpoquj) = mcybqzetak ahiskyjird (bokrtmudvy, kdlasrmewg - lwjmhfzlbx)
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