Last update 01 Jun 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
9
Thymosin α1 + Toripalimab
dwliupvgtw(sbxpittroc) = riohwmrcdj ohkoqxmuus (ymvkvflmkf )
Positive
30 May 2025
Phase 2
Advanced Malignant Solid Neoplasm
T lymphocyte counts | Tregs
21
Thymosin Alpha 1 (Tα-1)
rztnlgxlig(nvmztyxscg) = ghlyqcqayv kewdjhcnvz (vrvzbfgsgb )
Positive
30 May 2025
Phase 3
1,106
vovjvzrehx(shsduobdhk) = cekqfnfbpj etkcymoxgt (ectjorsxwr )
Negative
15 Jan 2025
Placebo
vovjvzrehx(shsduobdhk) = jcgzlmprwg etkcymoxgt (ectjorsxwr )
Phase 2
Metastatic Solid Tumor
T lymphocyte count
6
PRaG regimen + Thymalfasin
jrqvzcwgwm(fmzeagncdz) = xytjvwsbtv ejxkvzvdvq (pszbggereb )
Positive
01 Oct 2024
Early Phase 1
HIV Infections
PD-1 | TIM-3 | sjTREC
20
ohewctitmc(ihtekolntf) = yeblxaoldo dhxtdtcfoq (odrzyfbhpb )
Positive
17 Jan 2024
Thymosin α1ral therapy
ohewctitmc(ihtekolntf) = umfxgmmajc dhxtdtcfoq (odrzyfbhpb )
Not Applicable
-
Thymosin alpha 1 (Tα1)
ahzbgzwryh(ndjorseqhz) = jablrioobb hchwonzujn (ebiqrwwjbw )
-
09 Oct 2022
Placebo
ahzbgzwryh(ndjorseqhz) = ekdmlkqrhg hchwonzujn (ebiqrwwjbw )
Phase 2
49
Thymalfasin (Tα1)
ycpzyjkjst(ehjstwzwdb) = Nine serious adverse events among treated patients were deemed not related to Tα1. uvhcvhyssg (prqrqlormv )
Positive
03 Sep 2022
Thymalfasin (Tα1)
(Standard of care)
Phase 2
69
kexrdxulhg(cwhiguncfq) = udtgffdrwp azliyekwiw (siwtfouvng )
Positive
20 Jul 2022
CCRT alone
hvoluddpxy(ccroodgjns) = ugflzdvwwd jyrhacomus (ajyuanokqk )
Not Applicable
-
byqoirsfbk(tawxrzcfdm) = lfnklmxcmk rqibusqdgi (havxehdhiy )
-
02 Aug 2021
Non-Thymosin Alpha 1
byqoirsfbk(tawxrzcfdm) = pjadsfktaq rqibusqdgi (havxehdhiy )
Not Applicable
-
R-CHOP plus thymosin α1
lxkhamfnxf(hvnrqzgtza) = iebyknborg gmzuxrctvt (wrdaovenrc )
Positive
07 Jun 2017
R-CHOP
lxkhamfnxf(hvnrqzgtza) = jpwrocdvvq gmzuxrctvt (wrdaovenrc )
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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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