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Evidence: HighProtein, not a peptideNot FDA ApprovedRecombinant soluble thrombomodulinApproved in Japan 2008 · RecomodulinNot approved in the US or EU

Thrombomodulin Alfa

A recombinant form of the blood-vessel protein that switches thrombin from clotting to anticoagulation, used in Japan for disseminated intravascular coagulation

Thrombomodulin alfa is a recombinant, soluble form of human thrombomodulin. Thrombomodulin normally lines blood vessels, captures thrombin and turns it into an activator of protein C, a natural anticoagulant. Japan approved the drug in 2008 as Recomodulin for disseminated intravascular coagulation (DIC), the runaway clotting seen in sepsis and blood cancers, after it resolved DIC more often than heparin in a phase 3 trial. The international SCARLET trial in sepsis-associated coagulopathy did not show a survival benefit, and it is not approved in the US or Europe.

Manufacturer's recommended dosing (Japanese label): 380 U/kg (reduce as appropriate), Once daily, about 30-minute infusion, Intravenous infusion Details ↓

Overview

What is it?

Thrombomodulin is a protein on the inner surface of blood vessels. When thrombin, the enzyme that drives clotting, binds to it, thrombin stops making fibrin and instead activates protein C, which shuts down two clotting factors. Thrombomodulin alfa is a soluble recombinant form of that protein, produced by recombinant technology under the code ART-123 and sold in Japan as Recomodulin. Volunteer studies in 1998 found that a single injection lowered prothrombinase activity for two days, a sign that the protein C pathway had been switched on.

It lasts a long time for a protein drug. In healthy men its terminal half-life after an intravenous dose was about 20 hours, about half of a dose appeared in the urine within 48 hours, and repeated daily doses did not accumulate. Given under the skin, its half-life was two to three days, and a single dose kept prothrombinase inhibited for more than six days, which led to its study as a long-acting anticoagulant. Clearance falls with kidney function and body weight, and children with blood cancers cleared it faster per kilogram than adults.

Its approval rests on DIC. In a Japanese phase 3 trial of 234 patients with DIC from blood cancers or infection, a daily 30-minute infusion of 0.06 mg/kg for six days resolved DIC in 66% against 50% on continuous heparin, with fewer bleeding problems. Japan approved it in January 2008. Post-marketing surveillance of more than 3,500 patients, a one-arm trial in DIC from solid tumours, a small series in acute promyelocytic leukaemia and several meta-analyses have since described its use, with DIC scores falling and serious bleeding in a few per cent of patients.

Sepsis has been the harder test. A phase 2b trial of 741 patients with sepsis and suspected DIC found 28-day mortality of 17.8% on the drug against 21.6% on placebo, a difference not statistically significant but enough to continue. The phase 3 SCARLET trial then randomised 800 patients with sepsis-associated coagulopathy in 26 countries: 28-day mortality was 26.8% against 29.4%, not significant, with slightly more serious bleeding. Later analyses suggested benefit in patients whose coagulopathy persisted, who had high thrombin markers or who did not get heparin, and meta-analyses disagree on whether it lowers mortality. Japanese registry studies found lower in-hospital mortality in treated patients, but these were observational.

Other trials have been negative or exploratory. In acute exacerbation of idiopathic pulmonary fibrosis, a Japanese placebo-controlled phase 3 trial found 90-day survival of 72.5% on the drug against 89.2% on placebo, with more bleeding, and the authors advised against its use there. A phase 2 trial suggested it might reduce nerve damage from the cancer drug oxaliplatin. It remains a hospital drug approved only in Japan, given by intravenous infusion.

66% vs 50%
DIC resolved
thrombomodulin alfa vs heparin, phase 3 · PMID 17059423
26.8% vs 29.4%
28-day mortality in SCARLET
vs placebo, not significant · PMID 31104069
380 U/kg
Japanese label dose
once daily, 30-minute infusion (Japanese label)
Science

Mechanism of Action

Thrombomodulin alfa binds thrombin and turns it from a clotting enzyme into an activator of protein C, which switches off two activated clotting cofactors, so less new thrombin is made.

🔄

Thrombin switched to protein C activation

A single 0.3 mg dose cut prothrombinase activity by 44% to 61% over 48 hours in healthy men, a sign of protein C pathway activation (1998 volunteer study).

🩸

Less clotting without longer clotting times

In the phase 3 DIC trial it lowered thrombin-antithrombin complexes and spared antithrombin and protein C without prolonging aPTT, unlike heparin (2020 post hoc analysis).

⏳

Long half-life

About 20 hours intravenously and 2 to 3 days under the skin in volunteers (1998 and 2004 studies).

🚰

Kidney clearance

Clearance falls as creatinine clearance falls, from 0.158 to 0.105 L/h between normal and severe impairment in a population model (2015 analysis).

Evidence

Published Research

Studies of thrombomodulin alfa (ART-123, recombinant human soluble thrombomodulin) itself, read from their PubMed abstracts: volunteer pharmacology, the Japanese DIC trials and surveillance, the international sepsis trials, the pulmonary fibrosis and oxaliplatin trials, meta-analyses, and animal work.

Human2007

Phase 3 against heparin in DIC

In a double-blind, double-dummy trial in 234 patients with DIC from blood cancers or infection, ART-123 0.06 mg/kg over 30 minutes once daily for 6 days resolved DIC in 66.1% against 49.9% on heparin 8 U/kg per hour. Bleeding symptoms improved more, and bleeding-related adverse events in the first week were less common (43.1% vs 56.5%).

PMID: 17059423
Human2011

Phase 3 subgroup with infection

In the 80 patients from the phase 3 trial whose DIC came from infection, DIC resolved in 67.5% on thrombomodulin alfa against 55.6% on heparin, and 28-day mortality was 21.4% against 31.6%.

PMID: 21068698
Human2020

What changed in the blood

A post hoc analysis of the 227 patients in the Japanese phase 3 trial found that thrombomodulin alfa lowered thrombin-antithrombin complexes more than heparin and reduced the consumption of antithrombin and protein C, without lengthening aPTT, which may explain its lower bleeding risk.

PMID: 33134780
Human2019

SCARLET: no survival benefit in sepsis

In 800 patients with sepsis-associated coagulopathy at 159 intensive care units in 26 countries, 0.06 mg/kg per day (maximum 6 mg) for 6 days gave 28-day mortality of 26.8% against 29.4% on placebo (p = 0.32). Serious major bleeding occurred in 5.8% against 4.0%.

PMID: 31104069
Human2020

SCARLET by thrombin markers

In a post hoc analysis of SCARLET, mortality on placebo rose with baseline prothrombin fragment 1.2 and thrombin-antithrombin levels, but much less on the drug, so the absolute risk reduction was greater, about 4% to 5.5%, in patients with higher thrombin generation.

PMID: 32697484
Human2021

SCARLET in France

Among the 19% of SCARLET patients treated in France, the absolute reduction in 28-day mortality was 8.3% against 1.1% elsewhere, and 13% to 17% in French patients with persistent coagulopathy or no heparin, an exploratory finding; safety was similar.

PMID: 33788052
Human2013

Phase 2b in sepsis with suspected DIC

In 741 treated patients at 233 intensive care units in 17 countries, 0.06 mg/kg per day for 6 days gave 28-day mortality of 17.8% against 21.6% on placebo (p = 0.273), meeting the predefined signal for further study. Coagulation markers fell, and bleeding and new infections did not differ.

PMID: 23979365
Human2020

Worse, not better, in pulmonary fibrosis

In a Japanese placebo-controlled phase 3 trial in acute exacerbation of idiopathic pulmonary fibrosis, 380 U/kg per day for 14 days with high-dose steroids gave 90-day survival of 72.5% against 89.2% on placebo, and bleeding events were more frequent (23.8% vs 10.5%); the authors advised against this use.

PMID: 31917621
Human2020

Oxaliplatin nerve damage, phase 2

In 79 colon cancer patients on adjuvant mFOLFOX6, 380 U/kg infused on the first day of each cycle gave better neuropathy scores at cycle 12 than placebo, while three daily doses did not reach significance; there was no severe bleeding.

PMID: 32965539
Human2015

DIC from solid tumours

In a one-arm prospective trial in 101 patients with DIC from solid cancers, mostly lung, stomach and breast, 380 U/kg over 30 minutes daily for 6 to 14 days resolved DIC in 34%, and 28-day survival was 55.4%; drug-related bleeding occurred in 12.9%, none severe.

PMID: 25385713
Human2012

Acute promyelocytic leukaemia

Nine patients with DIC from acute promyelocytic leukaemia treated with it alongside retinoic acid and chemotherapy recovered from DIC sooner than eight historical controls, and none died of bleeding, while two controls had intracranial vascular events.

PMID: 22917769
Human2013

Surveillance in 3,548 patients

In Japanese post-marketing surveillance of DIC from infection (2,516) or blood cancers (1,032), DIC scores fell, critical bleeding reactions occurred in 2.6% and 2.4%, and survival was 64.1% and 70.7%; patients outside the phase 3 criteria fared worse in the blood-cancer group.

PMID: 23566534
Human2014

Surveillance in sepsis-induced DIC

Among 1,787 patients registered in 2008-2010, given an average 297 U/kg per day for 5.6 days, DIC resolved in 44.4% and 28-day survival was 66.0%, falling the longer DIC had lasted before treatment. Bleeding reactions occurred in 5.5%, and one patient (0.11%) had antibodies to the drug.

PMID: 25520842
Human2016

Registry: lower in-hospital mortality

In a retrospective study of 1,784 septic patients with DIC at 42 Japanese intensive care units, propensity-matched analysis linked treatment to lower in-hospital mortality (odds ratio 0.76) and longer survival, without more bleeding.

PMID: 26939575
Human1998

First volunteer pharmacokinetics

In 16 healthy men given 2-hour infusions, single doses of 0.03 to 0.3 mg declined in two phases with half-lives of about 4 and 20 hours; 54% to 60% appeared in urine within 48 hours, and 0.2 mg daily for 3 days did not accumulate or cause abnormal findings.

PMID: 9597558
Human1998

Switches on protein C in volunteers

A 0.3 mg intravenous bolus in four healthy men had an elimination half-life of about 19.8 hours and cut plasma prothrombinase activity by 44%, 52% and 61% immediately, at 24 and at 48 hours, without changing thromboelastography.

PMID: 9650544
Human2004

Phase 1 under the skin

In 55 healthy volunteers given 0.02 to 0.06 mg/kg intravenously or 0.02 to 0.45 mg/kg subcutaneously, the subcutaneous half-life was 2 to 3 days, and 0.30 or 0.45 mg/kg kept prothrombinase inhibition above 80% for more than 6 days, with no major bleeding.

PMID: 15456485
Human2015

Dosing in kidney impairment

A population model built from 24 healthy subjects and 368 septic patients with DIC found body weight and creatinine clearance drove clearance, which fell from 0.158 to 0.105 L/h between normal and severe impairment; 0.06 mg/kg was predicted to stay within the 300 to 5,400 ng/ml therapeutic range.

PMID: 27140801
Human2017

Children clear it faster

In children with blood cancers and DIC given 0.06 mg/kg (380 U/kg) over 30 minutes daily, clearance per kilogram was higher than in adults, and six of eight did not reach the target trough level, suggesting children need dose adjustment.

PMID: 27734584
Review2019

Five trials in sepsis coagulopathy

Pooling five randomised trials with 1,762 patients, including SCARLET, mortality was about 13% lower with the drug but not significantly (relative risk 0.87, 0.74 to 1.03), serious bleeding did not increase, and only 42% of the information needed for a firm answer was available.

PMID: 30597500
Review2020

Benefit limited to true coagulopathy

Across three randomised trials with 1,633 septic patients, the drug lowered 28-day mortality in those meeting criteria for sepsis-associated coagulopathy (relative risk 0.80) but not in those without it or in the whole population; major bleeding did not differ.

PMID: 32237269
Review2023

Seventeen studies in sepsis-induced DIC

Seventeen studies with 2,296 patients, mostly observational, linked treatment to lower mortality (odds ratio 0.54) and more DIC resolution (odds ratio 2.88), with no increase in bleeding.

PMID: 37182388
Review2024

DIC in blood cancers

One prospective and seven retrospective studies found higher DIC recovery and fewer bleeding adverse events with the drug in blood-cancer DIC, but no improvement in overall survival.

PMID: 38270783
Animal2009

Rat pharmacokinetics

In rats it was cleared in two phases with a terminal half-life of 6 to 8 hours, stayed mostly in plasma, was largely unchanged 72 hours after repeated doses, and its clearance fell only about 20% with kidney impairment.

PMID: 19255938
Animal2009

With antithrombin in septic rats

In rats given bacterial endotoxin, 0.25 mg/kg of recombinant soluble thrombomodulin and 125 IU/kg of antithrombin had similar effects on fibrinogen; only the combination protected platelets and fibrinogen together and improved 24-hour survival.

PMID: 20003418
Dosing

Dosing Data

The first rows are the Japanese package insert for Recomodulin, a Japanese label rather than an FDA one; the drug is not approved in the US. The other rows are doses given in the trials carded above. Trials often state the dose in mg/kg: 0.06 mg/kg corresponds to about 380 U/kg (1 mg = 6,400 U).

Thrombomodulin alfa is an intravenous anticoagulant given in hospital, mostly in intensive care, with monitoring for bleeding; it is approved only in Japan. These are label and trial doses, not recommendations, and nothing here is a dose to take on your own.
ProtocolDoseFrequencyDurationRoute
Recomodulin, adults with DIC (Japanese label) Approved labelRecomodulin Injection 12800 (thrombomodulin alfa) Japanese package insert, revised April 2026 (3rd edition), Asahi Kasei Therapeutics (JAPIC 00054575 via KEGG MEDICUS; PMDA-approved product; read October 29, 2026), Dosage and Administration380 U/kg (reduce as appropriate)Once daily, about 30-minute infusionExperience beyond 7 days is limited; stop when no longer neededIntravenous infusion
Recomodulin, DIC with severe kidney impairment (Japanese label) Approved labelRecomodulin Injection 12800 (thrombomodulin alfa) Japanese package insert, revised April 2026 (3rd edition), Asahi Kasei Therapeutics (JAPIC 00054575 via KEGG MEDICUS; PMDA-approved product; read October 29, 2026), Dosage and Administration130 U/kgOnce daily, about 30-minute infusionAs for the standard doseIntravenous infusion
DIC from blood cancers or infection, phase 3 against heparin (234 patients) Human studyPMID 170594230.06 mg/kgOnce daily over 30 minutes6 daysIntravenous
Sepsis-associated coagulopathy, SCARLET phase 3 (800 patients) Human studyPMID 311040690.06 mg/kg per day (maximum 6 mg)Once daily, bolus or 15-minute infusion6 daysIntravenous
Acute exacerbation of idiopathic pulmonary fibrosis, phase 3 (did not help) Human studyPMID 31917621380 U/kg per dayOnce daily, intravenous drip14 daysIntravenous

Educational information, not medical advice. Each dose above is tagged with its source: an approved label, a published human study, animal data, or amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.

Weight-based hospital infusion
Recomodulin comes as a 12,800 U (2 mg) vial and is dosed per kilogram as a daily infusion prepared by hospital staff.
For Buyers

What a Buyer Needs to Know

What is sold, how it is mixed, stored and taken, and what is known about its safety, quality and legal status. Each part names its source. Where we have none, it says unknown.

What is sold

Unknown: we hold no regulator's label that says in what form Thrombomodulin Alfa is supplied. It is prepared and given by clinical staff, not bought and mixed at home: the next part says where.

Mixing a vial: a worked example

Nothing to mix at home, and no syringe units to work out: Thrombomodulin Alfa is prepared and given by clinical staff, in hospital, mostly in intensive care.

In the carded trials it was infused into a vein for 6 days in patients with sepsis-related clotting problems at intensive care units.

Source: PMID 31104069 and PMID 23979365 (studies carded under Research below).

Storage before and after mixing

Unknown: no label on file says how Thrombomodulin Alfa is stored. It is kept and prepared by the hospital or clinic that gives it (see the part above); the home rules for a mixed vial in the mixing guide do not apply to it.

How it is taken

As the approved label gives it: Intravenous infusion (Once daily, about 30-minute infusion; Recomodulin, adults with DIC (Japanese label)).

Source: Manufacturer's recommended dosing (Japanese label): the route and frequency of each row in Dosing Data below.

What to expect, and when

How long it stays in the body: not established by a measurement cited on this entry.

How long the doses were given: Recomodulin, adults with DIC (Japanese label): Experience beyond 7 days is limited; stop when no longer needed; Recomodulin, DIC with severe kidney impairment (Japanese label): As for the standard dose.

When effects appear: unknown; no source on this page gives a time to effect for Thrombomodulin Alfa. Results reported in the studies are under Published Research.

Source: Manufacturer's recommended dosing (Japanese label), the duration of each row in Dosing Data below.

Side effects, and when to stop or get help

From the Side Effects section: Bleeding: serious major bleeding in 5.8% against 4.0% on placebo in SCARLET (PMID 31104069); bleeding reactions in about 5% in surveillance (PMID 25520842); More bleeding events in the pulmonary fibrosis trial (23.8% vs 10.5%) (PMID 31917621); Antibodies to the drug were rare, 0.11% in surveillance (PMID 25520842); Fewer bleeding-related events than heparin in the phase 3 DIC trial (PMID 17059423). Full list and cautions ↓

When to stop or get help: unknown; no label or trial on file sets rules for stopping Thrombomodulin Alfa. Treat a severe or unexpected reaction as a reason to stop and see a doctor.

Source: the Side Effects section below (“From the trials, surveillance studies and meta-analyses above”).

Interactions

Unknown: a PubMed search for human interaction studies of Thrombomodulin Alfa (reviewed 2026-10-28) found none. Unknown is not the same as safe to combine.

Every peptide's record, with its source: the interaction matrix.

Checking what you bought

Unknown: no published independent test of Thrombomodulin Alfa products is in our lab-results database yet, so how products sold under this name measure up is not known.

To read a certificate of analysis, paste it into the COA decoder; it checks the measured mass against Thrombomodulin Alfa's expected mass, 52,124.7 Da, from this entry's molecular data. Trust & Verification explains what independent testing can and cannot show.

Legal status

US: Not FDA Approved (Approved in Japan on January 25, 2008, as Recomodulin Injection 12800, a drug with a new active ingredient for disseminated intravascular coagulation (PMDA list of approved products)). Sport: Unsettled (S0 may apply).

Country by country ↓ · Regulatory tracker

Source: this entry's approval status and the WADA Prohibited List, as in Legal Status below.

Safety

Side Effects & Contraindications

Reported Side Effects

From the trials, surveillance studies and meta-analyses above.

● Bleeding: serious major bleeding in 5.8% against 4.0% on placebo in SCARLET (PMID 31104069); bleeding reactions in about 5% in surveillance (PMID 25520842)
● More bleeding events in the pulmonary fibrosis trial (23.8% vs 10.5%) (PMID 31917621)
● Antibodies to the drug were rare, 0.11% in surveillance (PMID 25520842)
● Fewer bleeding-related events than heparin in the phase 3 DIC trial (PMID 17059423)

Contraindications & Cautions

From the Japanese package insert (Recomodulin, revised April 2026):

● Not to be given with intracranial, pulmonary or ongoing gastrointestinal bleeding
● Not to be given after hypersensitivity to its ingredients, or in pregnancy or possible pregnancy
● Use only once DIC has been confirmed clinically; reduce to 130 U/kg in severe kidney impairment
● Spinal or epidural anaesthesia with anticoagulants can cause haematoma and paralysis; watch closely for nerve symptoms
Questions

Frequently Asked Questions

?What is thrombomodulin alfa?

A recombinant, soluble form of human thrombomodulin, the vessel-wall protein that turns thrombin into an activator of the natural anticoagulant protein C. It is sold in Japan as Recomodulin.

?What is it approved for?

Disseminated intravascular coagulation in Japan, where it was approved in 2008 after it resolved DIC more often than heparin in a phase 3 trial.

?Does it help in sepsis?

Not clearly. The international SCARLET trial found no significant difference in 28-day mortality against placebo; later analyses and Japanese observational studies suggest benefit in patients with marked coagulopathy, which needs confirming.

?What is the dose?

The Japanese label gives 380 U/kg once a day as a 30-minute intravenous infusion, reduced to 130 U/kg in severe kidney impairment. Trials often wrote this as 0.06 mg/kg.

?Is it available in the US or Europe?

No. It is not approved by the FDA or the EMA.

Bibliography

References

  1. [other] Pharmaceuticals and Medical Devices Agency (Japan), List of Approved Products, new drugs approved April 2004 to February 2026 (English edition, read October 28, 2026): Recomodulin Injection 12800 (thrombomodulin alfa, genetical recombination), approved January 25, 2008, a drug containing a new active ingredient indicated for the treatment of disseminated intravascular coagulation (DIC). https://www.pmda.go.jp/files/000281190.pdf
  2. [other] KEGG DRUG D06410: Thrombomodulin alfa (USAN/INN; JAN: genetical recombination), formula C2230H3357N633O718S50, molecular weight 52124.69, product listed in Japan. Read October 28, 2026. https://www.kegg.jp/entry/D06410
  3. [registry] ClinicalTrials.gov API v2, read October 28, 2026: NCT01598831 (phase 3, ART-123 in severe sepsis and coagulopathy, completed).
  4. [other] US FDA, Drugs@FDA (openFDA): no application for thrombomodulin alfa. Read October 28, 2026.
  5. [other] Recomodulin Injection 12800 (thrombomodulin alfa, genetical recombination), Japanese package insert, revised April 2026 (3rd edition), Asahi Kasei Therapeutics: dosage, renal reduction, contraindications and unit conversion. Read via KEGG MEDICUS (JAPIC 00054575) October 29, 2026.
  6. [clinical-trial] Saito H, et al. "Efficacy and safety of recombinant human soluble thrombomodulin (ART-123) in disseminated intravascular coagulation: results of a phase III, randomized, double-blind clinical trial." J Thromb Haemost, 2007;5(1):31-41. PMID: 17059423.
  7. [clinical-trial] Aikawa N, et al. "Thrombomodulin alfa in the treatment of infectious patients complicated by disseminated intravascular coagulation: subanalysis from the phase 3 trial." Shock, 2011;35(4):349-54. PMID: 21068698.
  8. [pubmed] Ito T, et al. "Effects of thrombomodulin alfa on hemostatic parameters in disseminated intravascular coagulation: Post hoc analysis of a phase 3 randomized controlled trial." Res Pract Thromb Haemost, 2020;4(7):1141-1149. PMID: 33134780.
  9. [clinical-trial] Vincent JL, et al. "Effect of a Recombinant Human Soluble Thrombomodulin on Mortality in Patients With Sepsis-Associated Coagulopathy: The SCARLET Randomized Clinical Trial." JAMA, 2019;321(20):1993-2002. PMID: 31104069.
  10. [clinical-trial] Levi M, et al. "Effect of a Recombinant Human Soluble Thrombomodulin on Baseline Coagulation Biomarker Levels and Mortality Outcome in Patients With Sepsis-Associated Coagulopathy." Crit Care Med, 2020;48(8):1140-1147. PMID: 32697484.
  11. [pubmed] François B, et al. "Efficacy and safety of human soluble thrombomodulin (ART-123) for treatment of patients in France with sepsis-associated coagulopathy: post hoc analysis of SCARLET." Ann Intensive Care, 2021;11(1):53. PMID: 33788052.
  12. [clinical-trial] Vincent JL, et al. "A randomized, double-blind, placebo-controlled, Phase 2b study to evaluate the safety and efficacy of recombinant human soluble thrombomodulin, ART-123, in patients with sepsis and suspected disseminated intravascular coagulation." Crit Care Med, 2013;41(9):2069-79. PMID: 23979365.
  13. [clinical-trial] Kondoh Y, et al. "Thrombomodulin Alfa for Acute Exacerbation of Idiopathic Pulmonary Fibrosis. A Randomized, Double-Blind Placebo-controlled Trial." Am J Respir Crit Care Med, 2020;201(9):1110-1119. PMID: 31917621.
  14. [clinical-trial] Kotaka M, et al. "A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy." Cancer Chemother Pharmacol, 2020;86(5):607-618. PMID: 32965539.
  15. [clinical-trial] Tamura K, et al. "Recombinant human soluble thrombomodulin (thrombomodulin alfa) to treat disseminated intravascular coagulation in solid tumors: results of a one-arm prospective trial." Int J Clin Oncol, 2015;20(4):821-8. PMID: 25385713.
  16. [clinical-trial] Ikezoe T, et al. "Recombinant human soluble thrombomodulin safely and effectively rescues acute promyelocytic leukemia patients from disseminated intravascular coagulation." Leuk Res, 2012;36(11):1398-402. PMID: 22917769.
  17. [pubmed] Mimuro J, et al. "Impact of recombinant soluble thrombomodulin (thrombomodulin alfa) on disseminated intravascular coagulation." Thromb Res, 2013;131(5):436-43. PMID: 23566534.
  18. [pubmed] Eguchi Y, et al. "Post-marketing surveillance data of thrombomodulin alfa: sub-analysis in patients with sepsis-induced disseminated intravascular coagulation." J Intensive Care, 2014;2(1):30. PMID: 25520842.
  19. [pubmed] Hayakawa M, et al. "Recombinant human soluble thrombomodulin and mortality in sepsis-induced disseminated intravascular coagulation. A multicentre retrospective study." Thromb Haemost, 2016;115(6):1157-66. PMID: 26939575.
  20. [pubmed] Nakashima M, et al. "Pharmacokinetics and safety of a novel recombinant soluble human thrombomodulin, ART-123, in healthy male volunteers." J Clin Pharmacol, 1998;38(1):40-4. PMID: 9597558.
  21. [clinical-trial] Nakashima M, et al. "A novel recombinant soluble human thrombomodulin, ART-123, activates the protein C pathway in healthy male volunteers." J Clin Pharmacol, 1998;38(6):540-4. PMID: 9650544.
  22. [clinical-trial] Moll S, et al. "Phase I study of a novel recombinant human soluble thrombomodulin, ART-123." J Thromb Haemost, 2004;2(10):1745-51. PMID: 15456485.
  23. [clinical-trial] Mouksassi MS, et al. "Population pharmacokinetic analysis of thrombomodulin alfa to support dosing rationale in patients with renal impairment." Clin Pharmacol Drug Dev, 2015;4(3):210-7. PMID: 27140801.
  24. [pubmed] Takeuchi M, et al. "Population pharmacokinetics of thrombomodulin alfa in pediatric patients with hematological malignancy and disseminated intravascular coagulation." Pediatr Blood Cancer, 2017;64(3). PMID: 27734584.
  25. [review] Yamakawa K, et al. "Recombinant Human Soluble Thrombomodulin in Sepsis-Induced Coagulopathy: An Updated Systematic Review and Meta-Analysis." Thromb Haemost, 2019;119(1):56-65. PMID: 30597500.
  26. [review] Valeriani E, et al. "Efficacy and safety of recombinant human soluble thrombomodulin in patients with sepsis-associated coagulopathy: A systematic review and meta-analysis." J Thromb Haemost, 2020;18(7):1618-1625. PMID: 32237269.
  27. [review] Kato H, et al. "Efficacy and safety of recombinant human soluble thrombomodulin in patients with sepsis-induced disseminated intravascular coagulation - A meta-analysis." Thromb Res, 2023;226:165-172. PMID: 37182388.
  28. [review] Kawano N, et al. "A systematic review and meta-analysis of recombinant human soluble thrombomodulin for the treatment of DIC associated with hematological malignancies." Int J Hematol, 2024;119(4):416-425. PMID: 38270783.
  29. [pubmed] Tsuruta K, et al. "Pharmacokinetics of recombinant human soluble thrombomodulin, thrombomodulin alfa in the rat." Xenobiotica, 2009;39(2):125-34. PMID: 19255938.
  30. [pubmed] Iba T, et al. "Combination effect of antithrombin and recombinant human soluble thrombomodulin in a lipopolysaccharide induced rat sepsis model." Crit Care, 2009;13(6):R203. PMID: 20003418.

Sources & Citations

Studies were read from their PubMed abstracts on October 29, 2026. The label is the Recomodulin Japanese package insert (revised April 2026), read through KEGG MEDICUS (JAPIC 00054575) on October 29, 2026; approval from the PMDA list of approved products; formula from KEGG DRUG; US and EU status from Drugs@FDA (openFDA) and the EMA list, read October 28, 2026. Grey Peptides sells nothing and links to no vendor.

Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Talk to a licensed clinician about your own situation.

Last reviewed: 2026-10-29