Market atlas / Amino-acid / glutathione / N-acetylcysteine

N-acetylcysteine (glutathione precursor)

repurposedsmall-moleculeglutathione-synthesisantioxidantmucolytic● glutathione

Stage by geography

Switzerland leads by 2 stages and reached it about 57 years before Japan.

signalpreclinfirst-in-humanRCTapprovedreal-worldconsumerUSCNJPCHSGILKRUK+2 stages

MarketsUS United States FDAUK United Kingdom MHRA / NICECN China NMPAIN India CDSCOJP Japan PMDACH Switzerland SwissmedicSG Singapore HSAIL Israel Ministry of HealthKR South Korea MFDS

What each market approved it for

Market	Stage	Since	Indication / class / form
US	approved	not dated	class Antidote [EPC]; Antidote for Acetaminophen Overdose [EPC]; Mucolytic [EPC]
UK	first-in-human	2017-06-08	not published
CN	approved	not dated	form Injection, chemical drug
JP	approved	2023-03-27	indication A drug with a new route of administration indicated for the support of pincer nail correction.
CH	approved	1966-06-23	indication Antidote for paracetamol (acetaminophen) poisoning
SG	approved	1989-06-17	form Granule, oral, pharmacy only
IL	approved	2022-12-31	indication Mucolytic in respiratory tract disorders where reduction of sputum viscosity is required.
KR	approved	1986-04-22	class Antitussives and expectorants [MFDS 02220]

China registers · NMPA

What each NMPA register actually approved. Reference approval NMPA H20249093. Domestic generics vs imported originator.

99domestic approvals

Forms listed: 6
Product: Acetylcysteine Injection
Form: injection
Strength: 30ml:6g
Holder: Sichuan Huiyu Pharmaceutical
Origin: China
Approved: 2024-10-16
Approval no: NMPA H20249093

5imported approvals

approval count only; per-product detail not captured

Biomarker trends

no biomarker readings yet

Studies

The studies on N-acetylcysteine, what they found, in whom and how strongly, are on its evidence page, each linked to its source.

What the trials measure

Registered primary outcomes this development's trials are powered on, commonest first (ClinicalTrials.gov). What is measured, across markets.

Registered primary endpoint	Markets measuring it
Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach	KR
Change from baseline in Clinician-administered PTSD scale scores at 4th weeks	KR
Change from baseline in Clinician-administered PTSD scale scores at 8th weeks	KR

Connections

Trajectory

1966

MarketCH: approved-other (Swissmedic-authorised (Switzerland))

Swissmedic:acetylcystein (1966-06-23) · machine-extracted

1986

MarketKR: approved-other (MFDS-approved (South Korea))

MFDS:acetylcysteine (1986-04-22) · machine-extracted

1989

MarketSG: approved-other (HSA-registered (Singapore))

HSA:acetylcysteine (1989-06-17) · machine-extracted

2011

Relatedshares a mechanism with Glycine

NCT01384591 · machine-extracted

2011

ProfileN-acetylcysteine (glutathione precursor)

NCT01384591 · machine-extracted

2017

MarketUK: first-in-human (early clinical (phase 1))

NCT03177395 · machine-extracted

2022

MarketIL: approved-other (Israel MoH-registered)

IsraelMoH:acetylcysteine (2022-12-31) · machine-extracted

2023

MarketJP: approved-other (PMDA-approved (Japan))

PMDA:acetylcysteine (2023-03-27) · machine-extracted

2026

MarketCH: rct (clinical trials (highest phase 3))

NCT05537220 · machine-extracted

2026

MarketIL: rct (clinical trials (highest phase 3))

NCT00267384 · machine-extracted

2026

MarketJP: rct (clinical trials (highest phase 3))

NCT01210456 · machine-extracted

2026

MarketKR: rct (clinical trials (highest phase 2))

NCT01664260 · machine-extracted

2026

MarketSG: rct (clinical trials (highest phase 3))

NCT00497328 · machine-extracted

2026

MarketCN: approved-other (NMPA-approved (domestic + imported))

NMPA:NMPA H20249093 · machine-extracted

2026

MarketUS: approved-other (approved, marketed)

NDA021539 · machine-extracted

Get into the weeds: raw observations + provenance

swissmedic__dev_nac__CH  2026-07-13  kind=geography_stage  verify=M
   Swissmedic-authorised in Switzerland: acetylcysteinum (Fluimucil 20 %, solution for infusion), first authorisation 1966-06-23. [Swissmedic list of authorised medicinal products]
   source Swissmedic:acetylcystein (1966-06-23)  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/erweiterte_ham_ind.xlsx

mfds__dev_nac__KR  2026-07-13  kind=geography_stage  verify=M
   MFDS-approved in South Korea: Acetylcysteine (Nucomyt Sol.), first approval 1986-04-22. [MFDS drug product-approval list]
   source MFDS:acetylcysteine (1986-04-22)  https://nedrug.mfds.go.kr/pbp/CCBGA01

hsa__dev_nac__SG  2026-07-13  kind=geography_stage  verify=M
   HSA-registered in Singapore: ACETYLCYSTEINE (FLUIMUCIL GRANULES 200 mg/sachet), first registration 1989-06-17. [HSA Listing of Registered Therapeutic Products]
   source HSA:acetylcysteine (1989-06-17)  https://data.gov.sg/datasets/d_767279312753558cbf19d48344577084/view

nac_edge_gly  2026-06-29  kind=edge  verify=M
   the GlyNAC pair (glutathione support)
   source NCT01384591  https://clinicaltrials.gov/study/NCT01384591

nac_facets  2026-06-29  kind=facets  verify=M
   NAC facets
   source NCT01384591  https://clinicaltrials.gov/study/NCT01384591

nac_uk  2026-06-29  kind=geography_stage  verify=M
   N-acetylcysteine: UK early-phase trials [NCT03177395]
   source NCT03177395  https://clinicaltrials.gov/study/NCT03177395

israelmoh__dev_nac__IL  2026-07-13  kind=geography_stage  verify=M
   Registered in Israel (Israeli Drug Registry): ACETYLCYSTEINE 200 MG (REOLIN EFFERVESCENT TABLETS 200 MG), current registration 2022-12-31. [Israel MoH Drug Registry]
   source IsraelMoH:acetylcysteine (2022-12-31)  https://israeldrugs.health.gov.il/

pmda__dev_nac__JP  2026-07-13  kind=geography_stage  verify=M
   PMDA-approved in Japan: Acetylcysteine (Renail Gel 10% (Maruho Co., Ltd.)), first approval 2023-03-27. [PMDA List of Approved Drugs]
   source PMDA:acetylcysteine (2023-03-27)  https://www.pmda.go.jp/files/000281190.pdf

ctsearch__CH__dev_nac  2026-07-10  kind=geography_stage  verify=M
   N-acetylcysteine: 2 registered trial(s) in CH, highest phase 3 [NCT05537220]
   source NCT05537220  https://clinicaltrials.gov/study/NCT05537220

ctsearch__IL__dev_nac  2026-07-10  kind=geography_stage  verify=M
   N-acetylcysteine: 9 registered trial(s) in IL, highest phase 3 [NCT00267384]
   source NCT00267384  https://clinicaltrials.gov/study/NCT00267384

ctsearch__JP__dev_nac  2026-07-10  kind=geography_stage  verify=M
   N-acetylcysteine: 1 registered trial(s) in JP, highest phase 3 [NCT01210456]
   source NCT01210456  https://clinicaltrials.gov/study/NCT01210456

ctsearch__KR__dev_nac  2026-07-10  kind=geography_stage  verify=M
   N-acetylcysteine: 5 registered trial(s) in KR, highest phase 2 [NCT01664260]
   source NCT01664260  https://clinicaltrials.gov/study/NCT01664260

ctsearch__SG__dev_nac  2026-07-10  kind=geography_stage  verify=M
   N-acetylcysteine: 1 registered trial(s) in SG, highest phase 3 [NCT00497328]
   source NCT00497328  https://clinicaltrials.gov/study/NCT00497328

nmpa__dev_nac__CN  2026-07-13  kind=geography_stage  verify=M
   NMPA-approved in China (acetylcysteine): 99 domestic approval(s) (e.g. Acetylcysteine Injection, 30ml:6g, Sichuan Huiyu Pharmaceutical, China); 5 imported approval(s). Reference NMPA H20249093.
   source NMPA:NMPA H20249093  https://www.nmpa.gov.cn/datasearch/home-index.html

openfda__NDA021539__US  2026-07-13  kind=geography_stage  verify=M
   FDA-approved in the US (ACETYLCYSTEINE); approved, marketed [NDA021539]
   source NDA021539  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA021539