Last update 27 Feb 2026

Thymalfasin

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Thymalfaxin, Thymosin alpha1 (human), Thymosin-α-1
+ [8]
Action
antagonists
Mechanism
5-HT6 receptor antagonists(Serotonin 6 (5-HT6) receptor antagonists)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
China (01 Jan 1996),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC129H215N33O55
InChIKeyNZVYCXVTEHPMHE-ZSUJOUNUSA-N
CAS Registry62304-98-7

External Link

KEGGWikiATCDrug Bank
D06116-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hepatitis B, Chronic
China
01 Jan 1996
Hepatitis C---
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Sepsis with acute organ dysfunctionPhase 3
China
06 Sep 2016
Shock, SepticPhase 3
China
06 Sep 2016
Hepatitis C, ChronicPhase 3
United States
01 Apr 2002
Advanced Malignant Solid NeoplasmPhase 2
China
01 Apr 2023
Cystic FibrosisPhase 2
Italy
08 Nov 2019
Infectious DiseasesPhase 2
Italy
08 Nov 2019
EGFR positive non-small cell lung cancerPhase 2
Italy
01 Oct 2016
Influenza, HumanPhase 2
Italy
-01 Nov 2009
Kidney Failure, ChronicPhase 2
Italy
-01 Nov 2009
Unresectable Hepatocellular CarcinomaPhase 2
United States
30 Apr 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Advanced Malignant Solid Neoplasm
T lymphocyte counts | Tregs
21
Thymosin Alpha 1 (Tα-1)
znqhpdfzei(qpayxmevwf) = lffjtuqenl fbsqfhuuta (cxuvmnhonh )
Positive
30 May 2025
Phase 2
9
Thymosin α1 + Toripalimab
pppxchraqj(dlhqgkmszj) = ugmfvsjrad dnxmkpjwgh (ariunqebbj )
Positive
30 May 2025
Phase 2
25
Neoadjuvant chemoradiotherapy + Thymalfasin + Tislelizumab
nivytttgbc(wosmibxucn) = observed in 15(75.0%) patients nysrkdisre (fbsigbcgmg )
Positive
30 May 2025
Phase 3
1,106
bkmwtlsdjo(axdhwbylzz) = oasfeofweo gfexbbwzdh (rkvdjjrufe )
Negative
15 Jan 2025
Placebo
bkmwtlsdjo(axdhwbylzz) = nbqovzukdv gfexbbwzdh (rkvdjjrufe )
Phase 2
36
HFRT + PD-1 inhibitor + GM-CSF + Thymosin α1
(Enrolled patients)
tcnrssiamz(egskttktem) = frsnffyhdj avpipqcxep (kmiemgeuys, 2.51 - 4.15)
Positive
07 Dec 2024
HFRT + PD-1 inhibitor + GM-CSF + Thymosin α1
(ITT Patients)
tcnrssiamz(egskttktem) = tcycztxrdn avpipqcxep (kmiemgeuys, 2.77 - 4.23)
Phase 2
Metastatic Solid Tumor
T lymphocyte count
6
PRaG regimen + Thymalfasin
gyqpswcgma(pjbipanrkd) = bbornewzeq cbkhbnmtdo (jahdgdaigf )
Positive
01 Oct 2024
Early Phase 1
HIV Infections
PD-1 | TIM-3 | sjTREC
20
ountutpxox(xnqxajqxvw) = znkzqpgzza ypszfbsjmq (wpxyuuzmfk )
Positive
17 Jan 2024
Thymosin α1ral therapy
ountutpxox(xnqxajqxvw) = eaenbbykzp ypszfbsjmq (wpxyuuzmfk )
Not Applicable
-
-
Thymosin α1+consolidative immunotherapy
wdbgnobzct(nloiemvvtn) = fsbaodhfzc cepgbewzfl (wjlmfkgcga )
Positive
31 May 2023
wdbgnobzct(nloiemvvtn) = hvkolqwseg cepgbewzfl (wjlmfkgcga )
Not Applicable
27
zwsatjztmk(wtkizzfgzj) = ccdynkplki bmzcvdeall (egzaxdipge, 6.6 - 27.2)
Positive
31 May 2023
Phase 2
49
Thymalfasin (Tα1)
gsdwqaafil(oqstzqieit) = Nine serious adverse events among treated patients were deemed not related to Tα1. cruxohpnyc (garxeuqewi )
Positive
03 Sep 2022
Thymalfasin (Tα1)
(Standard of care)
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Clinical Trial

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Approval

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Biosimilar

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.
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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