Drugs / Aminocaproic Acid
Aminocaproic Acid
also known as
Epsilon-aminocaproic acid · EACA · 6- amino-caproic acid · 177 J.D · ACA · Acide aminocaproique · Acido aminocaproico · Amicar · +10 more
Small molecule targets KLK5, PLAT, PLG via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | AMICAR | — | 1983-12-05 | fda.gov ↗ |
| Approved | US (FDA) | AMICAR | — | 1964-06-03 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01398280 | Jul 2011 → Dec 2012 | rosacea | University of California, San Diego | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT00912119 | May 2009 → Oct 2011 | craniosynostosis | Paul Stricker | Completed | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT04187014 | Feb 2020 → Apr 2021 | — | Carlos A Acosta-Olivo | Completed | No outcome recorded |
| Phase 2 | NCT03365999 | Oct 2017 → Jul 2019 | osteoarthritis, knee, thrombotic disease | Autonomous University of Nuevo León | Completed | Mixed |
| Phase 2 | NCT02074436 | May 2014 → Nov 2020 | hematopoietic and lymphoid cell neoplasm, thrombocytopenia | Emory University | Terminated | Missed primary Stop: Enrollment |
| Phase 31 trial | ||||||
| Phase 3 | NCT02655653 | Oct 2008 → Oct 2010 | hemorrhagic disease | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07644923 | Aug 2026 → Aug 2028 expected | — | NYU Langone Health | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04814433 | Mar 2021 → Jul 2023 | — | NYU Langone Health | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01981863 | Jul 2013 → Feb 2014 | fibrinolytic defect | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT00958581 | Dec 2008 → Sep 2012 | scoliosis | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT00156520 | Mar → Sep 2005 | hemorrhagic disease | University of Rochester | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00320619 | Sep 2000 → Feb 2006 | scoliosis, spinal stenosis, spondylitis | National Heart, Lung, and Blood Institute (NHLBI) | Completed | Mixed |
| Comparator or background therapy8 trials | ||||||
| Phase 2/3 | NCT00223704 Comparator | May 2006 → Jun 2012 | — | Vanderbilt University | Completed | Missed primary |
| Phase 4 | NCT02656472 Comparator | Feb 2016 → Apr 2017 | — | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 4 | NCT02030821 Comparator | Jan 2015 → Nov 2017 | osteoarthritis, hip, osteoarthritis, knee | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT02238288 Comparator | Dec 2013 → Dec 2014 | — | Grupo de Estudos Multicentricos em Onco-Hematologia | Unknown | No outcome recorded |
| — | NCT01527968 Comparator | Apr 2012 → Dec 2016 | osteoarthritis | Heekin Orthopedic Research Institute | Unknown | No outcome recorded |
| — | NCT01248104 Comparator | Mar 2010 → Mar 2013 | — | Loma Linda University | Completed | No outcome recorded |
| — | NCT00940745 Comparator | Jul 2009 → Mar 2010 | intracerebral hemorrhage | Huazhong University of Science and Technology | Unknown | No outcome recorded |
| — | NCT00752024 Background | Sep 2008 → Sep 2010 | intracerebral hemorrhage | Huazhong University of Science and Technology | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2019-12-02 | Impax Laboratories, LLC | Regulatory Amneal Announces the Approval and Launch of Generic Revatio® for Oral Suspension and Generic Amicar® Tablets amneal.com ↗
today announced that it has received final U.S. Food and Drug Administration (“FDA”) approval on its Abbreviated New Drug Applications (“ANDA”) for generic versions of Revatio® (sildenafil citrate) for Oral Suspension 10 mg/ml and Amicar® (aminocaproic acid) Tablets USP, 500 mg. |
| 2019-09-05 | Impax Laboratories, LLC | Regulatory Amneal Announces Approval of Generic Version of Amicar® amneal.com ↗
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its generic version of Amicar ® (aminocaproic acid oral solution) 0.25g/mL. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-12-02 | Impax Laboratories, LLC | Amneal Announces the Approval and Launch of Generic Revatio® for Oral Suspension and Generic Amicar® Tablets amneal.com ↗ |
| 2019-09-05 | Impax Laboratories, LLC | Amneal Announces Approval of Generic Version of Amicar® amneal.com ↗ |
| 2018-07-19 | Lotus Pharmaceutical | Sunny Pharmtech and Lotus Pharm announced partnership in aminocaproic acid tablets for the US lotuspharm.com ↗ |
Evidence & citations 25 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | aminocaproic acid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03365999 ↗ |
| Known as | 177 J.D | ChEMBL registry synonym — accepted as the source's own label CHEMBL1046 ↗ |
| Known as | 6- amino-caproic acid | “the ultra early patient may use anti-filament medicinal preparation 6- amino-caproic acid 6-12g/d, intravenous drip” NCT00940745 ↗1“anti-filament medicinal preparation 6- amino-caproic acid 6-12g/d” NCT00752024 ↗ |
| Known as | ACA | “Topical aminocaproic acid (ACA) mixed with Vanicream” NCT01398280 ↗ |
| Known as | Acide aminocaproique | ChEMBL registry synonym — accepted as the source's own label CHEMBL1046 ↗ |
| Known as | Acido aminocaproico | ChEMBL registry synonym — accepted as the source's own label CHEMBL1046 ↗ |
| Known as | Amicar | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02030821 ↗ |
| Known as | Amikar | “Medications: tranexamic acid (Lysteda, Pierre Fabre Mexico) or aminocaproic acid (Amikar, Wyeth), as appropriate, will be administered orally three times (administering 2...” NCT03365999 ↗ |
| Known as | Aminocaproic | ChEMBL registry synonym — accepted as the source's own label CHEMBL1046 ↗ |
| Known as | CL 10304 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1046 ↗ |
| Known as | CY-116 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1046 ↗ |
| Known as | EACA | “Tranexamic acid (AXA) and aminocaproic acid (EACA) are synthetic drugs derived from Lysine that competitively inhibit the lysine receptors in the plasminogen and plasmin...” NCT03365999 ↗4“intra-alveolar epsilon amino caproic acid (EACA) associated to daily rinses with the drug” NCT02238288 ↗ “epsilon aminocaproic acid (EACA) to reduce the number of red-cell (RBC) transfusions” PMID 19730217 ↗ Sep 2009 “Epsilon aminocaproic acid (EACA) blocks a process called fibrinolysis” NCT02074436 ↗ “epsilon aminocaproic acid (EACA)” NCT00156520 ↗ |
| Known as | Epsikapron | ChEMBL registry synonym — accepted as the source's own label CHEMBL1046 ↗ |
| Known as | Epsilcapramin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1046 ↗ |
| Known as | Epsilon-aminocaproic acid | “Epsilon-aminocaproic acid (EACA) and tranexamic acid (TXA) are synthetic amino acid derivatives that interfere with fibrinolysis, promoting hemostasis by pharmacological means.” PMID 28976426 ↗ Oct 201711“intra-alveolar epsilon amino caproic acid (EACA) associated to daily rinses with the drug” NCT02238288 ↗ “Epsilon aminocaproic acid (EACA) blocks a process called fibrinolysis” NCT02074436 ↗ “Epsilon-aminocaproic acid (Amicar)” NCT02030821 ↗ |
| Known as | Hexanoic acid, 6-amino- | ChEMBL registry synonym — accepted as the source's own label CHEMBL1046 ↗ |
| Known as | NSC-26154 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1046 ↗ |
| Known as | NSC-400230 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1046 ↗ |
| Known as | ε-aminocaproic acid | “In contrast, ε-aminocaproic acid (EACA), a similar acting antifibrinolytic to TXA, has been less frequently used.” PMID 27699724 ↗ Oct 2016 |
| Action | Inhibit | “blocks the lysine binding sites on plasminogen, resulting in antifibrinolytic activity through inhibition of plasmin formation.” NCT00912119 ↗ |
| Modality | Small molecule | — CHEMBL1046 ↗ |
| Route | Intravenous | “receive either epsilon aminocaproic acid (EACA) or aprotonin intravenously” NCT00156520 ↗ |
| Target | KLK5 | “inhibit Kallikrein 5 Serine Protease Activity” NCT01398280 ↗ |
| Target | PLAT | “Tissue-type plasminogen activator inhibitor” CHEMBL1046 ↗ |
| Target | PLG | “Plasminogen inhibitor” CHEMBL1046 ↗ |