Thymosin alpha 1
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00580450 | Dec 2007 | hematopoietic and lymphoid cell neoplasm | University Of Perugia | Unknown | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT07103395 | Jan 2026 → Dec 2029 expected | non-small cell lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT07103408 | Oct 2025 → Sep 2029 expected | small cell lung carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07644897 | May 2023 → May 2027 expected | melanoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT02976740 | Nov 2016 → Jun 2019 | lung cancer | The First Affiliated Hospital of Xiamen University | Unknown | No outcome recorded |
| Phase 2 | NCT02787447 | May 2016 → Dec 2017 | lung adenocarcinoma | First People's Hospital of Hangzhou | Unknown | No outcome recorded |
| Phase 2 | NCT01031966 | Nov 2009 → May 2010 | end stage renal failure | sigma-tau i.f.r. S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT00911443 | Jul 2002 → Sep 2007 | melanoma | sigma-tau i.f.r. S.p.A. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07675980 | Feb 2026 → Feb 2027 expected | infertility disorder | Fakih IVF Fertility Center | Recruiting | No outcome recorded |
| Phase 34 trials · 2 missed | ||||||
| Phase 3 | NCT05086614 | Apr 2021 → Mar 2027 expected | colorectal carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 3 | NCT04320238 | Jan → May 2020 | COVID-19 | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 3 | NCT02867267 | Sep 2016 → Jan 2021 | infectious disease with sepsis | Sun Yat-sen University | Completed | Missed primary |
| Phase 3 | NCT01178996 | Dec 2004 → May 2008 | chronic hepatitis C virus infection | sigma-tau i.f.r. S.p.A. | Completed | Missed primary |
| Phase 45 trials | ||||||
| Phase 4 | NCT06178146 | Sep 2023 → Nov 2024 | — | Jun Wang | Unknown | No outcome recorded |
| Phase 4 | NCT04524169 | Nov 2020 → Dec 2021 | osteoporosis | RenJi Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02473406 | Mar 2018 → Dec 2020 | acute necrotizing pancreatitis | Weiqin Li | Completed | No outcome recorded |
| Phase 4 | NCT03448744 | Oct 2017 → Dec 2018 | chronic hepatitis B virus infection | Wen-hong Zhang | Unknown | No outcome recorded |
| Phase 4 | NCT02883595 | Mar → Sep 2016 | infectious disease with sepsis | Sun Yat-sen University | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06607926 | Oct 2024 → Jun 2025 overdue | non-small cell lung carcinoma | Xuanwu Hospital, Beijing | Not yet recruiting | No outcome recorded |
| — | NCT06598839 | Jun 2024 → Sep 2025 overdue | non-small cell lung carcinoma | Yousheng Mao | Recruiting | No outcome recorded |
| — | NCT05487469 | Jul 2022 → Dec 2023 | rheumatic heart disease | Nanjing Medical University | Unknown | No outcome recorded |
| — | NCT05339529 | Jul 2022 → Mar 2025 | aortic disorder | Nanjing Medical University | Completed | No outcome recorded |
| — | NCT00711620 | May 2008 → Dec 2010 | infectious disease with sepsis | Sun Yat-sen University | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT00197860 Background | Sep 2004 → Dec 2009 | renal cell carcinoma | Inge Marie Svane | Completed | No outcome recorded |
| Phase 4 | NCT00291616 Comparator | Dec 2005 → Aug 2008 | chronic hepatitis B virus infection | Seoul National University Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-04-15 | SciClone Pharmaceuticals | Results 新辅助免疫化疗联合胸腺法新治疗局部进展期胃/胃食管结合部腺癌II期研究结果公布：病理完全缓解率达30%，免疫重塑揭示协同机制 sciclone.com ↗
日前发表于国际知名医学期刊BMC Medicine的一项研究显示，斯鲁利单抗联合SOX及胸腺法新的新辅助治疗方案，在局部进展期胃/胃食管结合部腺癌治疗中取得了令人鼓舞的病理学缓解，淋巴结病灶清除效果明显，且安全性可控。 |
| 2025-08-27 | SciClone Pharmaceuticals | Results 胸腺法新联合标准治疗可显著改善不可切除局部晚期非小细胞肺癌患者生存 sciclone.com ↗
长程Tα1联合CCRT序贯免疫巩固疗法显著改善患者生存。 |
| 2023-11-03 | SciClone Pharmaceuticals | Results 赛生药业首席医学官毛力：胸腺法新在肿瘤免疫治疗时代前景广阔 sciclone.com ↗
《胸腺法新对有淋巴细胞减少的晚期复发恶性实体瘤患者的安全性与有效性研究》结果则显示，在为经过多线治疗后复发或转移的目前无标准治疗晚期恶性实体瘤患者实施胸腺法新序贯布拉格治疗模式后，患者的外周血CD3 ＋ T细胞、CD3 ＋ CD4 ＋ T细胞、CD3 ＋ CD8 ＋ T细胞及NK细胞的数量均显著升高，患者的中位生存期达到近20个月。 |
| 2023-10-16 | SciClone Pharmaceuticals | Regulatory 胸腺法新作为新冠mRNA疫苗增强剂的临床试验申请获得美国FDA批准 sciclone.com ↗
赛生药业控股有限公司（“赛生药业”或“公司”，连同其附属公司，统称“集团”，股份代号：6600.HK）宣布，胸腺法新在老年人中作为新冠mRNA疫苗增强剂的临床研究已获得美国食品药品监督管理局（FDA）的临床试验许可。 |
| 2022-07-28 | SciClone Pharmaceuticals | Results 胸腺法新协同增效再添新证据：可显著减少局部晚期非小细胞肺癌同步放化疗所致的放射性肺炎 sciclone.com ↗
研究显示，局部晚期非小细胞肺癌（LANSCLC）患者在同步放化疗的同时接受胸腺肽α-1（即胸腺法新）的治疗，可显著减少2级及以上放射性肺炎和3~4级淋巴细胞减少症的发生。 |
| 2022-06-09 | SciClone Pharmaceuticals | Results 胸腺法新联合治疗可有效降低乙肝相关慢加急性肝衰竭患者病死率 sciclone.com ↗
结果显示，试验组90天非肝移植累积存活率（P=0.03）和180天的累积存活率（P=0.063）均高于对照组。 |
| 2021-11-12 | SciClone Pharmaceuticals | Results 研究显示胸腺法新可改善非小细胞肺癌患者的长期生存率 sciclone.com ↗
结果显示，Tα1组5年无病生存率(DFS) （77.3% v 64.7%, P < 0.0001）和总生存率(OS)（83.3% v 72.7%, P < 0.0001）明显高于对照组。 |
| 2016-06-07 | Replicor Inc. | Results Replicor announces publication of its REP 101 and REP 102 studies demonstrating the therapeutic effect of NAPs and the achievement of functional control off treatment in human patients with chronic hepatitis B infection. replicor.com ↗
In both studies, NAP monotherapy was accompanied by 2 – 7 log reductions of serum HBsAg, 3 – 9 log reductions in serum HBV DNA, seroconversion of HBeAg and the appearance of serum anti-HBsAg antibodies. |
| 2015-06-10 | Replicor Inc. | Results Replicor to Present at the Israel Association for the Study of Liver Conference and the Global Virus Hepatitis Summit in Berlin in June replicor.com ↗
The data from the previous three clinical trials, together with the preliminary data from the REP 301 trial, demonstrate that REP 2139 used alone or in combination with Pegasys® or ZADAXIN® or Pegasys® and ETV is safe and well-tolerated. |
| 2015-04-10 | Replicor Inc. | Results Replicor to Present at the 2015 Lancet Viral Hepatitis Conference replicor.com ↗
These clinical trials indicated that REP 2139-Ca appears to significantly increase the 12-month SVR rate achieved compared to existing therapies. |
| 2013-05-14 | Replicor Inc. | Results Replicor presents clinical efficacy and toxicology results in patients with chronic hepatitis B with short term exposure to immunotherapy after REP 2139-ca induced clearance of serum HBsAg. replicor.com ↗
Efficacy and toxicology results in Replicor’s proof of concept trials from monotherapy exposure to REP 2055 or REP 2139-ca were disclosed on Tuesday May 14th, 2013 at the 15 th annual TIDES meeting held in Boston, U.S.A. |
| 2013-04-26 | Replicor Inc. | Results Replicor presents updated clinical efficacy results in patients with chronic hepatitis B with short term exposure to immunotherapy in combination with REP 2139-ca and new clinical data in patients receiving this combination treatment while currently on entecavir (triple combination therapy). replicor.com ↗
Patients who had cleared HBsAg from their blood with REP 2139-ca monotherapy were subjected to combination treatment with REP 2139-ca and either Pegasys™ or Zadaxin™. |
| 2013-02-27 | Replicor Inc. | Results Replicor updates clinical efficacy results in patients with chronic hepatitis B with short term exposure to immunotherapy in combination with REP 2139 replicor.com ↗
Profound increases in anti-HBV antibodies or immune function were observed in all patients with as few as 6-10 weeks of combination treatment. |
| 2012-11-12 | Replicor Inc. | Results Replicor updates clinical results demonstrating the achievement of therapeutic vaccine-like responses in patients with chronic hepatitis B with short term exposure to immunotherapy in combination with REP 2139 replicor.com ↗
All patients have achieved HBV antibody levels seen in healthy patients after vaccination with a total of 12 weeks of combination treatment and many patients have achieved antibody titers > 1000 mIU / ml. |
| 2012-09-25 | Replicor Inc. | Results Replicor discloses achievement of therapeutic vaccine-like responses in patients with chronic hepatitis B with short term exposure to immunotherapy in combination with REP 2139 replicor.com ↗
Profound increases in anti-HBV antibodies or immune function were observed in all patients with as few as 6-10 weeks of combination treatment. |
All press releases naming this drug 15 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Thymosin-alpha1 | “In this post hoc analysis, we aimed to evaluate whether metabolic abnormalities impact the effect of immune-enhancing thymosin alpha-1 (Tα1) therapy in acute necrotizing...” PMID 38356344 ↗ Feb 202431“The neoadjuvant regimen prior to radiotherapy consists of albumin-bound paclitaxel/pemetrexed, cisplatin, Bevacizumab, iparomlimab and tuvonralimab, and thymosin alpha 1.” NCT07103395 ↗ “Thymosin alpha 1 (Tα1) is widely used to treat patients with COVID-19 in China; however, its efficacy remains unclear.” PMID 34408744 ↗ Aug 2021 “whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy” NCT03448744 ↗ “Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma” NCT00911443 ↗ “Thymosin alpha 1, 1.6mg injection hypodermic (I.H), every 12 hours for 5 days at least during the ICU admission.” NCT05339529 ↗ “Thymosin alpha 1, 1.6mg injection hypodermic (I.H), every 12 hours for 5 days at least during the ICU admission.” NCT05487469 ↗ “Immuno-chemotherapy regimen included etoposide, cisplatin, iparomlimab and tuvonralimab, and thymosin alpha 1.” NCT07103408 ↗ “Thymosin Alpha 1(1.6mg Biw)will be Subcutaneous injection from the fist week to the 12th weeks.” NCT02976740 ↗ “Thymosin-alpha1 regulates MHC class I expression in FRTL-5 cells at transcriptional level.” PMID 10741392 ↗ Mar 2000 “1,6 mg Thymosin alpha 1 (Zadaxin®, SciClone) is administered s.c. twice a week” NCT00197860 ↗ |
| Known as | Talpha1 | “Thymosin alpha1 (Talpha1), first described and characterized by Allan Goldstein in 1972, is used worldwide for the treatment of some immunodeficiencies, malignancies, and infections.” PMID 17495242 ↗ May 20072“Talpha1, a naturally occurring thymic peptide, primes dendritic cells (DCs) for antifungal T-helper type 1 resistance through Toll-like receptor 9 (TLR9) signaling.” PMID 16741252 ↗ Jun 2006 “In this study we examined the effect of the synthetic peptide thymosin-alpha1 (T(alpha)1) on MHC class I expression in FRTL-5 cells.” PMID 10741392 ↗ Mar 2000 |
| Known as | Thymosin a1 | “A Phase II, Multicentre, Open, Randomised, Dose Ranging Study to Investigate the Efficacy of Combination Therapy Containing Dacarbazine (DTIC) Plus Low Dose Interferon Alpha...” NCT00911443 ↗ |
| Known as | Thymosin-α1 | “Thymosin α1 (Tα1) immunomodulatory activity on effector cells of the innate immunity has been extensively described” PMID 23050812 ↗ Oct 20121“Thymosin-α1 (Tα1) is a naturally occurring thymic peptide with immune-modulatory properties.” NCT07675980 ↗ |
| Known as | Tα1 | “In this post hoc analysis, we aimed to evaluate whether metabolic abnormalities impact the effect of immune-enhancing thymosin alpha-1 (Tα1) therapy in acute necrotizing...” PMID 38356344 ↗ Feb 20246“Thymosin α1 (Tα1), a thymosin-related 28-mer synthetic amino-terminal acetylated peptide, has gained increasing interest in recent years, due to its pleiotropy.” PMID 23045964 ↗ Oct 2012 “Since it was first identified, thymosin alpha 1 (Tα1) has been characterized to have pleiotropic effects on several pathological conditions” PMID 23045967 ↗ Oct 2012 “Thymosin alpha-1 (Tα-1) has shown clinical benefits in patients whose immune functions are severely compromised or ineffective.” NCT06178146 ↗ “Thymosin alpha 1 (Tα1) is widely used to treat patients with COVID-19 in China; however, its efficacy remains unclear.” PMID 34408744 ↗ Aug 2021 “Thymosin-α1 (Tα1) is a naturally occurring thymic peptide with immune-modulatory properties.” NCT07675980 ↗ “thymosin alpha 1 (Tα1) is considered as a promising beneficial immunomodulatory drug.” PMID 23327199 ↗ Jan 2013 |
| Known as | Zadaxin | “1,6 mg Thymosin alpha 1 (Zadaxin®, SciClone) is administered s.c. twice a week” NCT00197860 ↗ |
| Modality | Peptide | “Thymosin α1 (Tα1), a thymosin-related 28-mer synthetic amino-terminal acetylated peptide” PMID 23045964 ↗ Oct 2012 |
| Route | Subcutaneous | “1,6 mg Thymosin alpha 1 (Zadaxin®, SciClone) is administered s.c. twice a week” NCT00197860 ↗ |
| Target | TLR9 | “through Toll-like receptor 9 (TLR9) signaling” PMID 16741252 ↗ Jun 2006 |