Drugs / Chenodeoxycholic Acid
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) | — | 2017-04-10 | europa.eu ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00004346 | Jan 1996 → ? | cerebrotendinous xanthomatosis | National Center for Research Resources (NCRR) | Unknown | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06260748 | May 2024 → Nov 2025 | cerebrotendinous xanthomatosis | Leadiant Biosciences, Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT04270682 | Jan 2020 → Jul 2023 | — | Mirum Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 45 trials | ||||||
| Phase 4 | NCT04640571 | Apr → Nov 2021 | — | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 4 | NCT03059537 | Mar → Nov 2017 | disorder of metabolite absorption and transport | Lars Kristian Munck | Completed | No outcome recorded |
| Phase 4 | NCT02952963 | Oct 2016 → Dec 2017 | morbid obesity | Hvidovre University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02876484 | Jun 2016 → Jun 2017 | morbid obesity | Hvidovre University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02340247 | Nov 2014 → Apr 2015 | obesity disorder | Hvidovre University Hospital | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT01666223 | Nov 2012 → Jun 2013 | obesity disorder, type 2 diabetes mellitus | University Hospital, Gentofte, Copenhagen | Completed | No outcome recorded |
| — | NCT00018694 | Oct 1999 → Dec 2009 | cerebrotendinous xanthomatosis | US Department of Veterans Affairs | Withdrawn | No outcome recorded |
| — | NCT00004442 | ? → Apr 1999 | Zellweger spectrum disorders, adrenoleukodystrophy, d-bifunctional protein deficiency | University of Cincinnati | Terminated | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 0 | NCT00465751 Comparator | Oct 2004 → ? | familial hyperlipidemia, hypertriglyceridemia 2, metabolic syndrome X | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 4 | NCT03168555 Background | Jun 2017 → May 2019 | cholelithiasis, malabsorption syndrome | Zealand University Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-02-24 | Mirum Pharmaceuticals, Inc. | Regulatory Mirum’s CTEXLI™ (chenodiol) Tablets Receives FDA Approval for Treatment of Cerebrotendinous Xanthomatosis (CTX) mirumpharma.com ↗
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved CTEXLI™ (chenodiol) tablets, a bile acid, for the treatment of adults with cerebrotendinous xanthomatosis (CTX). |
| 2024-06-28 | Mirum Pharmaceuticals, Inc. | Regulatory Mirum Submits New Drug Application to FDA for Chenodiol for the Treatment of CTX mirumpharma.com ↗
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced the submission of a new drug application (NDA) for chenodiol for the treatment of patients in the U.S. with cerebrotendinous xanthomatosis (CTX). |
| 2023-11-02 | Mirum Pharmaceuticals, Inc. | Results Mirum Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Update mirumpharma.com ↗
Announced positive Phase 3 data from the landmark RESTORE study evaluating CHENODAL in patients with CTX. |
| 2023-10-02 | Mirum Pharmaceuticals, Inc. | Results Mirum Pharmaceuticals Announces Positive Phase 3 RESTORE Study Results Evaluating Chenodal in Patients with Cerebrotendinous Xanthomatosis mirumpharma.com ↗
Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced positive data from the Phase 3 RESTORE study evaluating Chenodal® (chenodiol) tablets in 13 adult patients with cerebrotendinous xanthomatosis, or CTX. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-02-24 | Mirum Pharmaceuticals, Inc. | Mirum’s CTEXLI™ (chenodiol) Tablets Receives FDA Approval for Treatment of Cerebrotendinous Xanthomatosis (CTX) mirumpharma.com ↗ |
| 2024-06-28 | Mirum Pharmaceuticals, Inc. | Mirum Submits New Drug Application to FDA for Chenodiol for the Treatment of CTX mirumpharma.com ↗ |
| 2023-11-02 | Mirum Pharmaceuticals, Inc. | Mirum Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Update mirumpharma.com ↗ |
| 2023-10-02 | Mirum Pharmaceuticals, Inc. | Mirum Pharmaceuticals Announces Positive Phase 3 RESTORE Study Results Evaluating Chenodal in Patients with Cerebrotendinous Xanthomatosis mirumpharma.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Chenodeoxycholic Acid | “A Phase 3 Study to Evaluate the Effects of Chenodeoxycholic Acid in Adult and Pediatric Patients With Cerebrotendinous Xanthomatosis” NCT04270682 ↗ |
| Action | Inhibit | “replacement of chenodeoxycholic acid in the enterohepatic pool inhibit abnormal bile acid synthesis” NCT00018694 ↗ |
| Route | Oral | “oral cholic acid and oral chenodeoxycholic acid on day 1” NCT00004442 ↗ |