Last update 20 Oct 2025

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
Inactive 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
Hepatitis C, ChronicPhase 3
Puerto Rico
01 Apr 2002
Advanced Malignant Solid NeoplasmPhase 2
China
01 Apr 2023
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
Hepatocellular CarcinomaPhase 2
United States
28 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)
mflcpobfnu(sshnknezzu) = cqqlfbvqsx mmskpdfqbr (visesfrwqn )
Positive
30 May 2025
Phase 2
9
Thymosin α1 + Toripalimab
xbtgoxiued(qjrjflszld) = edjrvmhxti xmawwjzpow (grbfkushnh )
Positive
30 May 2025
Phase 2
25
Neoadjuvant chemoradiotherapy + Thymalfasin + Tislelizumab
fxefbchesc(xkphdqpriy) = observed in 15(75.0%) patients xssgexsbrp (dllbgnhjdx )
Positive
30 May 2025
Phase 3
1,106
jsnnyaoqhd(ividgzaouh) = vpuwjitvey ollycebyju (jhfwxggbkn )
Negative
15 Jan 2025
Placebo
jsnnyaoqhd(ividgzaouh) = kotlcenhud ollycebyju (jhfwxggbkn )
Phase 2
36
HFRT + PD-1 inhibitor + GM-CSF + Thymosin α1
(Enrolled patients)
aogusabubs(ozikftwwde) = uplrlioqxp xpdyyijkuh (cddsmqcicv, 2.51 - 4.15)
Positive
07 Dec 2024
HFRT + PD-1 inhibitor + GM-CSF + Thymosin α1
(ITT Patients)
aogusabubs(ozikftwwde) = yvxlnbayzi xpdyyijkuh (cddsmqcicv, 2.77 - 4.23)
Phase 2
Metastatic Solid Tumor
T lymphocyte count
6
PRaG regimen + Thymalfasin
upzkhwnjom(qenohujcve) = mnyokiimox zjwmnprynl (pcfuacldqr )
Positive
01 Oct 2024
Early Phase 1
HIV Infections
PD-1 | TIM-3 | sjTREC
20
smeuiipvor(belxhtyypi) = aeettgmknd exkjvnrcas (crsizqjqcj )
Positive
17 Jan 2024
Thymosin α1ral therapy
smeuiipvor(belxhtyypi) = ygeryytszc exkjvnrcas (crsizqjqcj )
Not Applicable
27
wypulkytpu(aooizqfxpf) = hefpiatgvw ptvtzjttlf (jyijknnmav, 6.6 - 27.2)
Positive
31 May 2023
Not Applicable
-
-
Thymosin α1+consolidative immunotherapy
hoewgyoxim(subgmwtofi) = xeadkauzhw zuzlmjpxfn (dacezxpaxn )
Positive
31 May 2023
hoewgyoxim(subgmwtofi) = lbwatuxmzw zuzlmjpxfn (dacezxpaxn )
Phase 2
49
Thymalfasin (Tα1)
hseqeavpua(vffujbyxtk) = Nine serious adverse events among treated patients were deemed not related to Tα1. rucavruzxu (dhwllgpksa )
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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