Drugs / vapreotide
vapreotide
also known as
BMY-41606 · BMY-41606 ACETATE · Docrised · Docrised (mexico) · DP-05-094 · Octastatin · Octastatin acetate · RC-160 · +5 more
Protein / enzyme biologic targets SSTR2, SSTR3, SSTR5 via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | Sanvar | esophageal varices with bleeding | 2006-07-24 | “filed a French marketing authorisation application (MAA) for Sanvar® in the treatment of patients with esophageal variceal bleeding (EVB).” debiopharm.com ↗ |
| Filed | US (FDA) | Sanvar | esophageal varices with bleeding | 2004-03-02 | “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in Washington DC for Sanvar® IR.” debiopharm.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00331188 | May 2006 → Jun 2008 | esophageal varices with bleeding, portal hypertension | Debiovision | Completed | Met primary |
| Phase 3 | NCT00014651 | Mar 2001 | malignant pancreatic neoplasm | Mayo Clinic | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2008-11-04 | Debiopharm International SA | Regulatory Sanvar® (Debio8609) for esophageal variceal bleeding – Debiopharm submits response to the FDA debiopharm.com ↗
Debiovision Inc., its Canadian affiliate, filed its Complete Response to the approvable letter received from the United States (U.S.) Food and Drug Administration (FDA) for Sanvar®, or Debio8609 (vapreotide acetate). |
| 2006-07-24 | Debiopharm International SA | Regulatory Debiopharm applies for first europe marketing authorisation for Sanvar® in France debiopharm.com ↗
The Debiopharm Group (Debiopharm), a global independent biopharmaceutical development company specialising in oncology and serious medical conditions filed a French marketing authorisation application (MAA) for Sanvar® in the treatment of patients with esophageal variceal bleeding (EVB). |
| 2005-01-04 | Debiopharm International SA | Regulatory H3 Pharma receives approvable letter from FDA for Sanvar® for esophageal variceal bleeding debiopharm.com ↗
In the letter, the FDA requests additional supportive efficacy data on the product candidate and additional information related to manufacturing aspects of the product. |
| 2004-08-24 | Debiopharm International SA | Regulatory Mexico becomes first country to approve H3 Pharma´s Sanvar® for esophageal variecal bleeding and four other indications debiopharm.com ↗
The decision in Mexico marks the first regulatory approval for Sanvar® IR in the world. |
| 2004-03-02 | Debiopharm International SA | Regulatory H3 Pharma Inc. Submits new drug application to FDA for Sanvar® IR debiopharm.com ↗
H3 Pharma Inc., a Montreal-based pharmaceutical Product Development Company, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in Washington DC for Sanvar® IR. |
| 2003-07-24 | Debiopharm International SA | Regulatory H3 Pharma Inc. announces important step in bringing SANVAR® (vapreotide) to U.S. market debiopharm.com ↗
“The FDA’s fileable letter marks another important step in bringing our range of SANVAR® products to market around the world,” said Dr. Loïc Maurel, M.D., President and CEO of H3 Pharma. |
| 2001-01-10 | Debiopharm International SA | Results Swiss drug developer Debiopharm S.A. achieves another success in the development of molecules for theraeutic use debiopharm.com ↗
The study shows that the infusion of vapreotide, started as soon as an upper digestive tract bleeding is suspected in a cirrhotic patient and maintained for five days, results in a significant improvement of haemostasis. |
All press releases naming this drug 12 releases
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | vapreotide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00014651 ↗ |
| Known as | BMY-41606 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3349523 ↗ |
| Known as | BMY-41606 ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3349523 ↗ |
| Known as | Docrised | ChEMBL registry synonym — accepted as the source's own label CHEMBL3349523 ↗ |
| Known as | Docrised (mexico) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3349523 ↗ |
| Known as | DP-05-094 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3349523 ↗ |
| Known as | Octastatin | ChEMBL registry synonym — accepted as the source's own label CHEMBL3349523 ↗ |
| Known as | Octastatin acetate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3349523 ↗ |
| Known as | RC-160 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3349523 ↗ |
| Known as | RC-160 ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3349523 ↗ |
| Known as | Sanvar | “Sanvar® (vapreotide) administered for 5 days in patients with acute variceal bleeding due to portal hypertension.” NCT00331188 ↗ |
| Known as | Vapreotida | ChEMBL registry synonym — accepted as the source's own label CHEMBL3349523 ↗ |
| Known as | vapreotide acetate | “Sanvar® (vapreotide acetate) 50 µg IV bolus followed by an IV continuous infusion of 50 µg/h for 5 days.” NCT00331188 ↗ |
| Known as | Vapreotide monoacetate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3349523 ↗ |
| Action | Activate | “Somatostatin receptor 5 agonist” CHEMBL3349523 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL3349523 ↗ |
| Route | Subcutaneous | “receive vapreotide subcutaneously twice daily on days 1-7.” NCT00014651 ↗ |
| Target | SSTR2 | “Somatostatin receptor 2 agonist” CHEMBL3349523 ↗ |
| Target | SSTR3 | “Somatostatin receptor 3 agonist” CHEMBL3349523 ↗ |
| Target | SSTR5 | “Somatostatin receptor 5 agonist” CHEMBL3349523 ↗ |