Apraglutide has been investigated in multiple clinical trials spanning Phase 1, Phase 2, and Phase 3 studies sponsored by entities including VectivBio AG and GlyPharma Therapeutics. These studies evaluate treatment efficacy, long-term safety, intestinal absorption capacity, and pharmacokinetics in healthy subjects as well as patients with short bowel syndrome, gastrointestinal graft-versus-host disease, chronic kidney disease, hepatic impairment, and adult lymphomas. Operational statuses across the clinical program currently include recruiting, active but not recruiting, and completed studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07742735 | RECRUITING | Short Bowel Syndrome (SBS); SBS Associated With Intestinal Failure (SBS-IF) |
VectivBio AG |
2026-08 | PHASE3 |
| NCT05018286 | ACTIVE_NOT_RECRUITING | Short Bowel Syndrome |
VectivBio AG |
2021-07-13 | PHASE3 |
| NCT05415410 | TERMINATED | GVHD |
VectivBio AG |
2022-05-25 | PHASE2 |
| NCT04627025 | COMPLETED | Short Bowel Syndrome |
VectivBio AG |
2021-01-26 | PHASE3 |
| NCT06002555 | COMPLETED | Healthy Subjects |
VectivBio AG |
2023-05-23 | PHASE1 |
| NCT05995704 | COMPLETED | Healthy Subjects |
VectivBio AG |
2023-03-02 | PHASE1 |
| NCT04964986 | COMPLETED | Short Bowel Syndrome |
VectivBio AG |
2021-06-14 | PHASE2 |
| NCT06002555 | Completed | Healthy Subjects |
VectivBio AG |
2023-05-23 | Phase 1 |
| NCT05706623 | COMPLETED | Hepatic Impairment |
VectivBio AG |
2023-01-30 | PHASE1 |
| NCT05995704 | Completed | Healthy Subjects |
VectivBio AG |
2023-03-02 | Phase 1 |
| NCT05706623 | Completed | Hepatic Impairment |
VectivBio AG |
2023-01-30 | Phase 1 |
| NCT05415410 | Active not recruiting | GVHD |
VectivBio AG |
2022-05-25 | Phase 2 |
| NCT04699032 | COMPLETED | Chronic Kidney Disease |
VectivBio AG |
2020-12-08 | PHASE1 |
| NCT04964986 | Completed | Short Bowel Syndrome |
VectivBio AG |
2021-06-14 | Phase 2 |
| NCT04627025 | Completed | Short Bowel Syndrome |
VectivBio AG |
2021-01-26 | Phase 3 |
| NCT03415594 | COMPLETED | Short Bowel Syndrome |
GlyPharma Therapeutics |
2018-05-08 | PHASE1; PHASE2 |
| NCT03408132 | COMPLETED | SBS - Short Bowel Syndrome |
GlyPharma Therapeutics |
2018-05-02 | PHASE1; PHASE2 |
| NCT03417765 | WITHDRAWN | Lymphoma, Non-Hodgkin's, Adult; Lymphoma, Hodgkin's, Adult |
GlyPharma Therapeutics |
2018-09-01 | PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-08-04)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).