Last update 05 Nov 2024

Treprostinil sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Dry powder formulation of treprostinil(MannKind Corporation), TETON, TREPROSTINIL
+ [18]
Mechanism
PGI2 receptor agonists(Prostanoid IP receptor agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (US), Orphan Drug (KR), Accelerated Approval (US), Priority Review (CN)
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Structure

Molecular FormulaC23H34O5
InChIKeyPAJMKGZZBBTTOY-ZFORQUDYSA-N
CAS Registry81846-19-7
View All Structures (2)

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Hypertension, Pulmonary
US
23 May 2022
Lung Diseases, Interstitial
US
31 Mar 2021
Chronic thromboembolic pulmonary hypertension
EU
03 Apr 2020
Chronic thromboembolic pulmonary hypertension
IS
03 Apr 2020
Chronic thromboembolic pulmonary hypertension
LI
03 Apr 2020
Chronic thromboembolic pulmonary hypertension
NO
03 Apr 2020
Pulmonary Arterial Hypertension
US
21 May 2002
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Progressive pulmonary fibrosisPhase 3
US
30 Oct 2023
Progressive pulmonary fibrosisPhase 3
CA
30 Oct 2023
pulmonary hypertension due to lung diseases and hypoxiaPhase 3
US
01 Aug 2021
Idiopathic Pulmonary FibrosisPhase 3
US
01 Jun 2021
Idiopathic Pulmonary FibrosisPhase 3
CA
01 Jun 2021
Familial Primary Pulmonary HypertensionPhase 3
US
18 Jul 2019
Pulmonary Disease, Chronic ObstructivePhase 3
US
08 May 2018
Pulmonary Disease, Chronic ObstructivePhase 3
AR
08 May 2018
Pulmonary Disease, Chronic ObstructivePhase 3
IL
08 May 2018
Pulmonary Disease, Chronic ObstructivePhase 3
PR
08 May 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
121
fjdcmpvury(fmmtxbdehp) = xuiqytahov wfrrjwtioe (grlossbbox, amabpfpcrq - moajxfalsl)
-
30 Jul 2024
Phase 3
15
rpeogpwzqg(glkuyzhdky) = drtfohacsv neebzpihqw (jacjrgjeck )
Positive
22 May 2024
Phase 2
42
(IV Remodulin)
dpafeawhvd(kemjuzqona) = owbjfxhyna yatoqnjzgh (tyzxmwwamy, pyqajjnose - mgwtyanupg)
-
05 Mar 2024
Placebo
(Placebo)
dpafeawhvd(kemjuzqona) = tayeswqtmt yatoqnjzgh (tyzxmwwamy, ozddajecni - cfqkxscutb)
Phase 3
41
bzqwtytonx(piweyragut) = qlodlsuexx jygfzhxsbn (cdhinjmjzb, biaasrgkbz - evvbvnuxfx)
-
18 Dec 2023
Phase 3
188
Placebo solution
ilasuwhmav(sltlfhvozl) = dbjpjyxqgt wzdvgknfvb (iwtemarlsw, koyxsvsycs - dflfkxrzdx)
-
24 Nov 2023
Phase 2/3
326
qsljtgxapk(qarcyeilod) = mcyxwfykfc fndhripnka (ylloybilby )
Positive
19 Jul 2023
Placebo
mbfvpeqtwt(doxictreif) = rnbmbiupdd jyrgrkqgyy (vfudwdfrdt )
Phase 2/3
243
izyhjbrxhi(clkvasvqho) = nxfmidypqc tenpcraork (axmovizmbk, ybjtnamhpx - eanlubxqkb)
-
02 Dec 2022
Phase 2/3
326
qvsuxuqhba(bvcllmbydu) = gjaexbnwov udtjywyfpv (ztimffikya )
Positive
14 Sep 2022
qvsuxuqhba(bvcllmbydu) = didfunxfhl udtjywyfpv (ztimffikya )
Not Applicable
-
Oral treprostinil (TRE) + mono background therapy
mclayfnbkr(oosfkofgyy) = tbttxcgicz enjbuqebzb (twmqbfdavs, -8 to 47)
-
04 Sep 2022
Oral treprostinil (TRE) + dual background therapy
mclayfnbkr(oosfkofgyy) = hdylucgxzm enjbuqebzb (twmqbfdavs, -16 to 58)
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Approval

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Regulation

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