COMPANY
Mirum Pharmaceuticals
FDA-approved therapeutic company Clinical Phase 3
Hiring
| Title | Location (from posting) | Employer posted | First seen |
|---|---|---|---|
| Vice President, Program Leadership (Launch Products) | Foster City | Oct 20, 2026 | Oct 21, 2026 |
| Executive Vice President, Head of International | Foster City | Oct 20, 2026 | Oct 21, 2026 |
| Senior Manager, Program Management | Foster City | Oct 19, 2026 | Oct 20, 2026 |
| Senior Director, HR Business Partner | Foster City | Oct 14, 2026 | Oct 15, 2026 |
| Director, Regulatory Project Management | Foster City | Oct 12, 2026 | Oct 12, 2026 |
Trial and FDA signals
- Drug approval + hiring FDA novel approval for ATEBRIOZ (NDA 221198, Sep 25, 2026); since then posted 2 manufacturing/quality or commercial roles. FDA NDA 221198 (Sep 25, 2026)
Evidence (1 event)
- Sep 25, 2026 · FDA NDA 221198
openFDA drugsfda: application_number=NDA221198; sponsor_name='MIRUM'; submission_type=ORIG; submission_number=1; submission_status=AP; submission_status_date=20260925; submission_class_code=TYPE 1; brand_name=['ATEBRIOZ']
- Sep 25, 2026 · FDA NDA 221198
Funding and NIH signals
- SEC Form D raise Raised $68.48M (Form D filed Jan 29, 2026); since then posted 71 roles. SEC Form D 0001759425-26-000005 (Jan 29, 2026)
Evidence (1 event)
- Jan 29, 2026 · SEC Form D 0001759425-26-000005
Name of Issuer: Mirum Pharmaceuticals, Inc.; CIK: 1759425; Address: Foster City, CA; Submission type: D; Filing date: 2026-01-29; Industry Group: Biotechnology; Date of First Sale: 2026-01-23; Types of Securities Offered: Equity; Business combination transaction: false; Total Offering Amount: 68480000; Total Amount Sold: 68480000; Federal exemptions: 06c
- Jan 29, 2026 · SEC Form D 0001759425-26-000005
Timeline
- Trial start Phase 2: MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP) source ↗
- Trial start Phase 1: A Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379 source ↗
- Debt Debt: $600M (not counted as a raise), announced May 12, 2026. Source: SEC filing. source ↗
- Trial start Phase 2/Phase 3: Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide source ↗
- Trial start Phase 3: A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4) source ↗
- Raise Private placement: amount not published, announced Dec 19, 2025. Source: SEC filing. source ↗
- Trial start Phase 2: Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM) source ↗
- Trial start Phase 4: Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union ( source ↗
- Trial start Phase 3: A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2) source ↗
- FDA FDA Original approval: LIVMARLI (maralixibat chloride) — NDA219485, Apr 10, 2025. Applicant at approval: Mirum Pharmaceuticals, Inc. source ↗
- Trial start Phase 2/Phase 3: A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection source ↗
- FDA FDA Original approval: CTEXLI (chenodiol) — NDA219488, Feb 21, 2025. Applicant at approval: Mirum Pharmaceuticals, Inc. source ↗
- Trial start Phase 3: Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND) source ↗
- Trial start —: Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US) source ↗
- Trial start Phase 2: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis source ↗
- Trial start Phase 2: A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagil source ↗
- Trial start Phase 2: Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai source ↗
- Trial start Phase 2: A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA) source ↗
- Trial start Phase 2: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) source ↗
- Trial start Phase 3: Study to Evaluate Patients With Cerebrotendinous Xanthomatosis (RESTORE) source ↗
- Trial start Phase 2: MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study source ↗
- Trial start Phase 3: An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC) source ↗
- Trial start Phase 3: A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC) source ↗
- Trial start Phase 3: A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC) source ↗
- Trial start —: The REPLACE Registry for Cholbam® (Cholic Acid) source ↗
Upcoming milestones
- 2026-10 (ESTIMATED) · Phase 3 · Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND) · NCT06553768
- 2027-01 (ESTIMATED) · Phase 2 · A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis · NCT05050136
- Jun 30, 2027 (ESTIMATED) · Phase 3 · A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2) · NCT07200908
- Aug 31, 2027 (ESTIMATED) · Phase 2/Phase 3 · Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide · NCT07454837
- 2027-10 (ESTIMATED) · Phase 2 · Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM) · NCT07209462
- Sep 20, 2028 (ESTIMATED) · · Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US) · NCT06193928
- Jan 12, 2029 (ESTIMATED) · Phase 2 · MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP) · NCT07823127
- 2029-05 (ESTIMATED) · Phase 2/Phase 3 · A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection · NCT06907290
Funding
Clinical trials (lead sponsor) 39
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07200908 | A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2) | Phase 3 | Recruiting | Aug 27, 2025 | Jun 30, 2027 (estimated) |
| NCT06193928 | Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US) | Not listed | Recruiting | Sep 21, 2023 | Sep 20, 2028 (estimated) |
| NCT07712718 | A Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379 | Phase 1 | Completed | May 29, 2026 | Jul 8, 2026 (actual) |
| NCT06553768 | Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND) | Phase 3 | Active, not recruiting | Oct 14, 2024 | 2026-10 (estimated) |
| NCT07209462 | Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM) | Phase 2 | Recruiting | Nov 22, 2025 | 2027-10 (estimated) |
| NCT07823127 | MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP) | Phase 2 | Not yet recruiting | Jan 15, 2027 | Jan 12, 2029 (estimated) |
| NCT07454837 | Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide | Phase 2/Phase 3 | Recruiting | Feb 26, 2026 | Aug 31, 2027 (estimated) |
| NCT04663308 | A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) | Phase 2 | Active, not recruiting | Dec 18, 2020 | Feb 20, 2026 (actual) |
| NCT05050136 | A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis | Phase 2 | Active, not recruiting | Sep 22, 2021 | 2027-01 (estimated) |
| NCT03115086 | The REPLACE Registry for Cholbam® (Cholic Acid) | Not listed | Active, not recruiting | Jul 10, 2017 | 2038-07 (estimated) |
| NCT07298330 | A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4) | Phase 3 | Active, not recruiting | Jan 14, 2026 | 2026-08 (estimated) |
| NCT07290257 | Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU) | Phase 4 | Recruiting | Sep 25, 2025 | Sep 22, 2030 (estimated) |
| NCT04185363 | An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC) | Phase 3 | Completed | Jan 8, 2020 | Apr 23, 2025 (actual) |
| NCT04729751 | A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS). | Phase 2 | Completed | Sep 9, 2021 | Dec 17, 2024 (actual) |
| NCT06907290 | A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection | Phase 2/Phase 3 | Active, not recruiting | Mar 25, 2025 | 2029-05 (estimated) |
| NCT04168385 | MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study | Phase 2 | Completed | Jan 16, 2020 | Sep 4, 2024 (actual) |
| NCT04524390 | Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai | Phase 2 | Completed | Jul 8, 2021 | Nov 7, 2023 (actual) |
| NCT04270682 | Study to Evaluate Patients With Cerebrotendinous Xanthomatosis (RESTORE) | Phase 3 | Completed | Jan 31, 2020 | Jul 13, 2023 (actual) |
| NCT04718961 | A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA) | Phase 2 | Terminated | Jan 4, 2021 | Dec 7, 2022 (actual) |
| NCT03905330 | A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC) | Phase 3 | Completed | Jul 9, 2019 | Sep 1, 2022 (actual) |
| NCT02057718 | Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis | Phase 2 | Completed | Mar 1, 2014 | May 8, 2020 (actual) |
| NCT00007020 | Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid | Phase 3 | Completed | 1992-01 | 2009-12 (actual) |
| NCT01438411 | Open Label, Continuation Study of Cholic Acid in Subjects With Inborn Errors of Bile Acid Synthesis | Phase 3 | Completed | 2010-01 | 2016-07 (actual) |
| NCT01115582 | Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis | Phase 3 | Completed | 2010-04 | 2010-08 (actual) |
| NCT02047318 | An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS) | Phase 2 | Completed | Dec 20, 2013 | Jun 17, 2020 (actual) |
| NCT04530994 | A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS) | Not listed | Approved for marketing | Not listed | Not listed |
| NCT02160782 | Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS) | Phase 2 | Completed | Oct 28, 2014 | May 28, 2020 (actual) |
| NCT02117713 | An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome | Phase 2 | Completed | Mar 16, 2015 | Jun 1, 2020 (actual) |
| NCT02787304 | Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) | Phase 2 | Terminated | Oct 24, 2016 | Jul 27, 2018 (actual) |
| NCT02571192 | A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose | Phase 1 | Completed | Oct 1, 2015 | Oct 1, 2015 (actual) |
| NCT02475317 | Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adults as Assessed by Fecal Bile Acid Excretion | Phase 1 | Completed | Jun 1, 2015 | Dec 1, 2015 (actual) |
| NCT02061540 | Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis | Phase 2 | Completed | 2014-03 | 2016-02 (actual) |
| NCT01903460 | Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome | Phase 2 | Completed | 2013-08 | 2015-02 (actual) |
| NCT01904058 | Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis | 2 | Completed | 2013-08 | 2015-04 (actual) |
| NCT02287779 | Safety and Tolerability Study of SHP626 in Overweight and Obese Adults | Phase 1 | Completed | Jan 19, 2015 | Jun 19, 2015 (actual) |
| NCT02057692 | Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome | Phase 2 | Completed | Nov 24, 2014 | Nov 16, 2016 (actual) |
| NCT02321306 | An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis | Phase 2 | Withdrawn | 2015-05 | 2017-12 (estimated) |
| NCT02131623 | Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease | Not listed | Completed | 2014-07 | 2015-03 (actual) |
| NCT03353454 | A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC) | Phase 3 | Withdrawn | Oct 25, 2018 | Jun 15, 2020 (estimated) |
FDA records (last 2 years)
Raises and investors new
- Raise Private raise (SEC Form D): $68.5M sold; issuer “Mirum Pharmaceuticals, Inc.”. Verified from the SEC filing. SEC filing ↗
Open jobs 73
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