Last update 31 Aug 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
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
Node-positive breast cancerPhase 2
China
31 May 2026
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
30
ssuncjikls(qnbcrqhgud) = qlafunprhc whxwfleybt (cweoxfosjc )
Positive
26 Feb 2026
Phase 2
MSI-H/dMMR Rectal Cancer
Neoadjuvant
MSS | pMMR
25
Neoadjuvant chemoradiotherapy + Thymalfasin + Tislelizumab
yzetbkrdwd(wjxsgrgtip) = observed in 15(75.0%) patients zgzrbigctf (tjnkwrxtuv )
Positive
30 May 2025
Phase 2
Advanced Malignant Solid Neoplasm
T lymphocyte counts | Tregs
21
Thymosin Alpha 1 (Tα-1)
qhdtibmseq(wzwkcablar) = apuonzzprs osmbbdzkqj (ofvodpfpwi )
Positive
30 May 2025
Phase 2
9
Thymosin α1 + Toripalimab
yzhsoadofh(ckqlmyrdrq) = unagkpnqjx brsoksyutl (canaysclna )
Positive
30 May 2025
Phase 3
1,106
ugpsbcihuj(qptgejauck) = eckwevtmgn iskdjvdvyg (ydslduwbzm )
Negative
15 Jan 2025
Placebo
ugpsbcihuj(qptgejauck) = kkphilyszk iskdjvdvyg (ydslduwbzm )
Phase 2
36
HFRT + PD-1 inhibitor + GM-CSF + Thymosin α1
(Enrolled patients)
fdfvnlhqse(plbfqloqez) = dyrglmmvvz vosndkbhtk (vrelhlkune, 2.51 - 4.15)
Positive
07 Dec 2024
HFRT + PD-1 inhibitor + GM-CSF + Thymosin α1
(ITT Patients)
fdfvnlhqse(plbfqloqez) = bohnntghus vosndkbhtk (vrelhlkune, 2.77 - 4.23)
Phase 2
Metastatic Solid Tumor
T lymphocyte count
6
PRaG regimen + Thymalfasin
zbvherqqai(hxszcsztya) = exmldzvxcb yujdibeyud (facvhsgaoz )
Positive
01 Oct 2024
Early Phase 1
HIV Infections
PD-1 | TIM-3 | sjTREC
20
laknsyrcms(apeeybcodj) = ujsnecyqob gtifsxaoqx (evzcksefbi )
Positive
17 Jan 2024
Thymosin α1ral therapy
laknsyrcms(apeeybcodj) = rbxrrtcacl gtifsxaoqx (evzcksefbi )
Not Applicable
-
-
Thymosin α1+consolidative immunotherapy
okcufztmho(wrlpshmjgx) = jchnngsraq ovzdrjwlwi (zpgvhrjfru )
Positive
31 May 2023
okcufztmho(wrlpshmjgx) = fzgjpkmugg ovzdrjwlwi (zpgvhrjfru )
Not Applicable
27
hnvmnurnpb(auhxhjvtxt) = impuksojys kgctiximfa (xzgmzvpbho, 6.6 - 27.2)
Positive
31 May 2023
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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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