Thymosin alpha 1
PMID 35616850 reports that 75.0% were alive without a liver transplant at day 90 with Thymosin alpha 1 plus standard care (checked: 2026-08-26). The share was 53.4% with standard care alone. The reported groups contained 114 people. NCT03082885 lists 120 enrolled. It names Sun Yat-sen University as sponsor. Crossref's publisher data lists six public grants from China.
A later phase 3 sepsis trial found no clear effect on deaths (PMID 39814420; checked: 2026-08-26). It included 1,089 people in its main analysis. Public research groups and SciClone Pharmaceuticals funded it.
| Corrected phase 3 result | Thymosin alpha 1 | Placebo | Effect |
|---|---|---|---|
| Death by day 28 | 23.4% | 24.1% | HR 0.97 (95% CI 0.76–1.24) |
The trials asked different questions in people with different diseases. They do not show what the peptide will do for a healthy user.
For the liver trial, a person had to be alive and not have a transplant at day 90. Death or a transplant meant the person did not meet that test.
What is Thymosin alpha 1?
The GSRS record for UNII W0B22ISQ1C names the substance thymalfasin (checked: 2026-08-26). This Thymosin alpha 1 peptide has 28 amino acids. GSRS gives CAS 62304-98-7. It lists ZADAXIN as a brand name. The register also carries the short form Talpha1.
The original sequence paper is PMID 265536 (checked: 2026-08-26). It described an immunologically active thymic polypeptide.
Thymosin alpha 1 is not thymosin beta-4. Their names are close, but the peptides are different.
The brand name does not prove where a medicine is authorized. The Italian record below does that.
What did the randomized liver-failure trial report?
PMID 35616850 was an open-label randomized trial (checked: 2026-08-26). It studied people with hepatitis-B-related acute-on-chronic liver failure. The reported groups included 56 people with Thymosin alpha 1 plus standard care. The other group had 58 people with standard care alone. The registry gives 120 as total enrollment.
| Finding in PMID 35616850 | Thymosin alpha 1 plus standard care | Standard care | Reported comparison | Funding beside the result |
|---|---|---|---|---|
| 90-day transplant-free survival | 75.0% (95% CI 63.2–86.8%) | 53.4% (95% CI 39.7–67.1%) | p = 0.030 | Six public grants in publisher metadata |
| New infection | 32.1% | 58.6% | p = 0.005 | Six public grants in publisher metadata |
| Hepatic encephalopathy | 8.9% | 24.1% | p = 0.029 | Six public grants in publisher metadata |
| Death from severe infection | 8.9% | 24.1% | p = 0.029 | Six public grants in publisher metadata |
A separate competing-risk test found no clear survival difference in PMID 35616850. The abstract gives no numerical table of unwanted events.
The main test favored the group that got the peptide. The other survival test did not show a clear gap. The two tests did not give the same answer.
Crossref's publisher data gives this funding list (checked: 2026-08-26):
| Public funder in publisher data | Awards |
|---|---|
| National Major Science and Technology Projects of China | 2 |
| National Natural Science Foundation of China | 2 |
| Natural Science Foundation of Guangdong Province | 1 |
| Guangzhou Research Collaborative Innovation Projects | 1 |
What did the corrected phase 3 sepsis trial report?
PMID 39814420 was a double-blind phase 3 trial (checked: 2026-08-26). It ran at 22 centres in China. The trial assigned 1,106 adults with sepsis at random. Its main analysis included 542 people with Thymosin alpha 1. It included 547 people with placebo.
| Corrected finding in PMID 39814420 | Thymosin alpha 1 | Placebo | Effect | Trial funding |
|---|---|---|---|---|
| 28-day mortality | 127/542 (23.4%) | 132/547 (24.1%) | HR 0.97 (95% CI 0.76–1.24); p = 0.82 | Sun Yat-sen programmes, Guangdong centre, SciClone |
| 90-day mortality | 31.0% | 32.4% | HR 0.95 (95% CI 0.77–1.17); p = 0.61 | Sun Yat-sen programmes, Guangdong centre, SciClone |
| At least one adverse event | 360/542 (66.4%) | 370/547 (67.6%) | Difference −1.2 points (95% CI −6.8 to 4.4); p = 0.70 | Sun Yat-sen programmes, Guangdong centre, SciClone |
| At least one serious adverse event | 145/542 (26.8%) | 160/547 (29.3%) | Difference −2.5 points (95% CI −7.8 to 2.8); p = 0.38 | Sun Yat-sen programmes, Guangdong centre, SciClone |
This trial was far larger than the earlier liver study. Its main result did not show a benefit.
A hazard ratio near one means the death rates over time were close in this trial. The range crossed one, so it did not show a clear gap.
PMID 40447307 is the May 2025 correction (checked: 2026-08-26). COVID-19 service breaks had affected checks at some trial sites. This page uses the corrected full text.
| Corrected value | Old paper | Corrected paper |
|---|---|---|
| 28-day hazard ratio | 0.99 | 0.97 |
| 90-day hazard ratio | 0.94 | 0.95 |
The paper says no secondary outcome differed clearly between groups. It calls the subgroup findings possible differences, not treatment results.
| Preset subgroup in PMID 39814420 | Hazard ratio for 28-day mortality | Interaction |
|---|---|---|
| Age below 60 | 1.67 (95% CI 1.04–2.67) | Age interaction p = 0.01 |
| Age 60 or older | 0.81 (95% CI 0.61–1.09) | Age interaction p = 0.01 |
| Diabetes | 0.58 (95% CI 0.35–0.99) | Diabetes interaction p = 0.04 |
| No diabetes | 1.16 (95% CI 0.87–1.53) | Diabetes interaction p = 0.04 |
A subgroup can point to a new test. It does not replace the main result.
The paper gives this funding list:
| Funder for PMID 39814420 | Disclosure |
|---|---|
| Sun Yat-sen University Clinical Research Program 5010 | Two grants |
| Guangdong Clinical Research Center for Critical Care Medicine | One grant |
| SciClone Pharmaceuticals | Commercial funder |
The paper says the funders did not design or run the work. It says they did not interpret the data or prepare the paper.
What adverse events did the sepsis trial record?
The paper lists these common events:
| Event in PMID 39814420 | Share |
|---|---|
| Anaemia | 10.7% |
| Fever | 9.6% |
| Abdominal distension | 5.4% |
| Coagulation disorders | 4.8% |
The paper reports no unexpected serious event related to Thymosin alpha 1.
What did the EU cystic-fibrosis trial report?
EU trial 2024-518102-41-00 was an ended phase 2 study in cystic fibrosis (checked: 2026-08-26). It analysed 24 people. Sciclone Pharmaceuticals International (SG) Pte. Ltd. sponsored it.
The final CTIS report gives these results:
| Finding in CTIS 2024-518102-41-00 | Result | Limit |
|---|---|---|
| Decrease above 30% in at least one measured cytokine | 16 of 23 people (69.6%) | Changes were not statistically significant |
| Lung function | Positive trend through week 8 | Not statistically significant |
| Quality-of-life domains | Positive trends | Not statistically significant |
| Combined cytokine score | Not calculated | No result |
| Elastase, C-reactive protein and sweat chloride | Exploratory trends | Not statistically significant |
The CTIS report gives no confidence intervals. It describes no placebo or control group.
This was a small study with no control group. The trends can guide more work. They do not prove that the drug helped.
A trend can rise or fall by chance. The report needs a clear test before it can call a result.
What adverse events did the cystic-fibrosis trial record?
The CTIS report gives this safety tally:
| Safety finding in CTIS 2024-518102-41-00 | Result |
|---|---|
| Unwanted events | 96 events in 21 people |
| Link to study product | 3 unlikely; 93 unrelated |
| Severity | 98% mild; 2 events moderate |
| Serious events | 8; all thought unrelated |
The report found no safety signal in vital signs or ECG. It found none in breathing tests, lab tests, or physical exams.
The report says most events were mild. It did not link the serious events to the drug.
What is the regulatory status?
EU register status: authorised (checked: 2026-08-26). The official CTIS product record gives these fields:
| CTIS product field | Value |
|---|---|
| Product | ZADAXIN® 1,6 mg/ml |
| Active substance | Thymalfasin |
| Marketing-authorization number | 028364026 |
| Country | Italy |
| Holder | Sciclone Pharmaceuticals Italy Srl |
This is a national Italian authorization. It is not a central EMA authorization. It does not prove approval in every EU member state. The CTIS fields read do not state the approved use. This page does not infer one.
A drug can have a national approval without a central EMA approval. The two routes are not the same.
Italy approved this product. The central EMA route did not supply the proof used here.
The fact comes from Italy's product record, not from the brand name.
That is why the two routes stay apart.
Evidence tier: B (checked: 2026-08-26). Marketing status and human evidence are separate fields. The page has not linked a named approved use to qualifying phase 3 evidence.
An approval is not proof that every use works.
What does grey-market vial testing show?
The 2026 vial-study text lists fourteen compounds (checked: 2026-08-26). It includes thymosin beta-4. It does not include Thymosin alpha 1 or thymalfasin.
The similar names do not make beta-4 and alpha 1 the same peptide.
The paper supplies no Thymosin alpha 1 report count. It gives no amount or identity result. It gives no purity, endotoxin, or sterility result for this peptide.
That paper cannot tell us what was in a vial sold as Thymosin alpha 1.
→ What vial testing can and cannot show
When was Thymosin alpha 1 first observed outside research?
No sound first grey-market month is known (checked: 2026-08-26). The Italian authorization is not a grey-market vendor record. The register therefore keeps first_observed: null.
A drug approval does not show when a grey-market vial first went on sale.
What do users report?
These accounts are self-reported and self-selected. They are free of anyone's money. They show what two writers said, not frequency or cause.
One r/Peptides writer reported both a perceived benefit and an unwanted effect:
“Thymosin alpha-1 helped me a lot with my chronic sinusitis problem. However, it causes my hands to swell. It feels like having carpal tunnel syndrome in both hands.”
Another r/Peptides writer explicitly said other compounds prevented attribution:
“Can’t say I noticed much but I was running other stuff too so it’s hard to attribute what effects to what. However it did for sure completely obliterate some althetes foot I couldn’t get rid of for like a year.”
These two accounts do not establish a consensus.