Drugs / BL-7010
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT01990885 | Dec 2013 → Oct 2014 | celiac disease | BioLineRx, Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2016-01-25 | BioLineRx, Ltd. | Regulatory BioLineRx Receives Confirmation of Medical Device Classification in Europe for Celiac Treatment biolinerx.com ↗ |
| 2014-11-05 | BioLineRx, Ltd. | Results BioLineRx Announces Successful Final Results of Phase 1/2 Study for Novel Celiac Treatment biolinerx.com ↗
BL-7010 was found to be safe and well tolerated in both single- and repeated-dose administrations, and the optimal safe dose for future development was determined. |
| 2014-08-21 | BioLineRx, Ltd. | Regulatory BioLineRx Receives Notice of Allowance for US Patent on BL-7010 Covering Use of Novel Polymer in Prevention of Gluten Toxicity biolinerx.com ↗ |
| 2014-08-06 | BioLineRx, Ltd. | Results BioLineRx Reports Second Quarter 2014 Financial Results biolinerx.com ↗
We also announced unblinded results of our Phase 1/2 safety study for BL-7010, our novel, non-absorbable, |
| 2014-07-16 | BioLineRx, Ltd. | Results BioLineRx Announces Results from Phase 1/2 Study for Celiac Treatment biolinerx.com ↗
BL-7010 was well-tolerated over 14 days of treatment, with only one patient not completing the 14-day treatment period. |
| 2014-06-11 | BioLineRx, Ltd. | Regulatory BioLineRx Receives Notice of Allowance for US Patent Covering Novel Treatment for Celiac Disease biolinerx.com ↗ |
| 2014-03-10 | BioLineRx, Ltd. | Results BioLineRx Completes Dose Escalation Stage of Phase 1/2 Study for Novel Celiac Treatment biolinerx.com ↗
No serious adverse events were reported and there were no dose-limiting safety issues. |
| 2013-11-04 | BioLineRx, Ltd. | Regulatory BioLineRx Receives Regulatory Approval to Commence Phase 1/2 Trial for Novel Treatment of Celiac Disease biolinerx.com ↗
BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that it has received regulatory approval from the Finnish National Supervisory Authority for Welfare and Health (Valvira) to commence a Phase 1/2 safety trial for BL-7010, for the treatment of celiac disease. |
| 2013-09-24 | BioLineRx, Ltd. | Regulatory BioLineRx Announces Regulatory Submission for Phase 1/2 Trial for Novel Treatment of Celiac Disease biolinerx.com ↗ |
| 2012-09-10 | BioLineRx, Ltd. | Results BioLineRx Announces Pre-clinical Results Demonstrating the Safety of BL-7010, an Oral Treatment for Celiac Disease and Gluten Sensitivity biolinerx.com ↗
BioLineRx (NASDAQ: BLRX; TASE: BLRX), a biopharmaceutical development company, announced today that BL-7010, an orally available treatment for celiac disease, was found to be safe and well tolerated in pre-clinical studies conducted to date. |
| 2012-02-21 | BioLineRx, Ltd. | Results BioLineRx Announces Publication of Pre-clinical Results Demonstrating Efficacy of BL-7010, an Oral Treatment for Celiac Disease and Gluten Sensitivity biolinerx.com ↗
BioLineRx (NASDAQ: BLRX; TASE: BLRX), a biopharmaceutical development company, announced the publication of pre-clinical results demonstrating that BL-7010, an orally available treatment for celiac disease, reduces gluten toxicity (the negative effect of gluten on the patient’s body). |
All press releases naming this drug 12 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BL-7010 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01990885 ↗ |
| Route | Oral | “single oral administration” NCT01990885 ↗ |