Section 3 of 6
Product information and disease description
78 evidence topics · 59 sources
Product description
Phase of product development
Orphan designation and FDA approval status
| Field | Quoted record |
|---|---|
| Date designated | “01/26/2021” |
| FDA orphan approval status | “Not FDA Approved for Orphan Indication” |
FDA review
| Field | Quoted information |
|---|---|
| NDA review designation | “Priority Review” |
| PDUFA target action date | “November 27, 2026” |
Launch: Anticipated in April 2027, the start of Zydus fiscal year 2028
Approvals outside the United States: MASH and MASLD publication
Exact FDA submission date; FDA Advisory Committee meeting date
No evidence found.
Product information
Generic, brand name and therapeutic class of product
Product and sponsor
| Field | Quoted record |
|---|---|
| Generic name | “saroglitazar magnesium” |
| Sponsor | “Zydus Therapeutics Inc.” |
U.S. brand name
No evidence found.
Dosage forms and strengths
MedChemExpress research-reagent safety data sheet
| Field | Quoted information |
|---|---|
| Product name | “Saroglitazar (magnesium)” |
| Catalog number | “HY-19937A” |
| CAS number | “1639792-20-3” |
| Identified uses | “Laboratory chemicals, manufacture of substances.” |
Zydus finished-product safety data sheet
No evidence found.
Average sales price and wholesale acquisition cost
Anticipated U.S. price, wholesale acquisition cost, and annual treatment-cost range
No evidence found.
American hospital formulary service (AHFS), or other drug classification
Mechanistic classification
AHFS classification code
No evidence found.
Indication
FDA orphan-designated indication
| Field | Quoted record |
|---|---|
| Orphan designation | “Treatment of Primary Biliary Cholangitis (PBC)” |
Pharmacology
Mechanism of action
Pharmacodynamics
Preclinical PPAR transactivation assay in HepG2 cells
| Receptor | Saroglitazar EC50 |
|---|---|
| hPPARα | “0.65 pmol/L” |
| hPPARγ | “3 nmol/L” |
Pharmacokinetics
Contraindications/Warnings/Precautions/Adverse effects
Warnings and precautions
Not applicable.
Special populations
Hepatic impairment: single-dose study
| Population or parameter | Quoted finding |
|---|---|
| Mild and moderate hepatic impairment | “did not significantly affect the PK of saroglitazar” |
| Severe hepatic impairment: exposure | “increased 3-fold” |
| Severe hepatic impairment: clearance | “61% lower” |
| Severe hepatic impairment: authors’ qualification | “may require close monitoring or dose adjustments” |
Cholestatic cirrhosis and renal impairment: moderate hepatic impairment in PBC cirrhosis
Cholestatic cirrhosis and renal impairment: single-dose pharmacokinetics in non-cirrhotic cholestatic liver disease and severe renal impairment
Pregnancy, lactation, and pediatric use
No evidence found.
Drug/Drug, drug/disease interactions
Effects of other drugs on Saroglitazar
No evidence found.
Effects of Saroglitazar on other drugs
Clinical drug-interaction studies
No evidence found.
Dosing and administration
Dosage
EPICS-III: active-moiety dose
Administration
Access and distribution
Commercialization strategy: earnings-call publication
Commercial patient-assistance program; pharmacy distribution network
No evidence found.
Co-prescribed/Concomitant therapies
Proposed indication: UDCA combination therapy and monotherapy
| Proposed use | Quoted population |
|---|---|
| Combination with UDCA | “adults who have had an inadequate response to UDCA” |
| Monotherapy | “patients unable to tolerate UDCA” |
Effect of Saroglitazar on quality measures
Saroglitazar-specific effect on quality measures
No evidence found.
Product comparison
Network meta-analysis including saroglitazar
Place of product in therapy
Disease description
Definition and etiology
Epidemiology
Incidence of Primary biliary cholangitis
Prevalence of Primary biliary cholangitis
Natural history, survival, and mortality
Ten-year survival by ALP level one year after study enrollment
| ALP category | Reported ten-year survival |
|---|---|
| At or below 2.0 times ULN | “alkaline phosphatase levels ≤ 2.0 times the ULN, 84% survived for 10 years” |
| Above 2.0 times ULN | “62% of those with levels >2.0 times the ULN” |
Pathophysiology
Diagnosis
Clinical presentation - signs and symptoms
Dermatologic symptoms: pruritus
Long-term morbidity
Hepatic and extrahepatic complications
| Complication domain | Quoted condition |
|---|---|
| Fibrosis | “Cirrhosis” |
| Vascular | “Portal hypertension” |
| Hepatic function | “liver failure” |
| Malignancy | “liver cancer” |
| Skeletal | “osteoporosis” |
| Nutritional | “low levels of fat-soluble vitamins A, D, E, and K” |
Burden of Primary biliary cholangitis
Humanistic burden and health-related quality of life
Validation of pruritus and patient-reported outcome instruments
Economic burden and healthcare resource utilization
Pruritus-associated healthcare utilization and costs
Fatigue or pruritus: matched case-control study
Population-based cost-of-illness study
Economic impact of Primary biliary cholangitis on families
Modeled informal-caregiver productivity losses
Economic impact of diagnostic testing
No evidence found.
Approaches to treatment
Current treatment options and standard of care
Hydrophilic bile acids
Peroxisome Proliferator-Activated receptor agonists
Comparator prescribing information: elafibranor
Fibrates
Bile acid sequestrants
Pruritus: first-line pharmacologic treatment
Rifamycins
Pruritus: second-line pharmacologic treatment
Ileal bile acid transporter inhibitors
Linerixibat: FDA approval for cholestatic pruritus
Opioid antagonists
Pruritus: naltrexone
Selective serotonin reuptake inhibitors
Supportive and nonpharmacological care
Fatigue: nonpharmacological care
Prevention of skeletal complications
Liver transplantation
Limitations of current therapies
Summary
UDCA is first-line treatment, while fibrates remain off-label alternatives and are discouraged in decompensated liver disease. The seladelpar prescribing information states that improved survival or prevention of liver decompensation has not been demonstrated. Obeticholic acid is no longer a current U.S. option: FDA withdrawal of approval took effect on November 24, 2025. Symptom management also remains incomplete; in TARGET-PBC, 33% of participants reporting clinically significant pruritus had never received treatment for it.
Seladelpar: clinical-outcome limitation
Obeticholic acid: U.S. withdrawal announcement
Obeticholic acid: withdrawal of FDA approval
Place in treatment, anticipated use, and care setting
Summary
The proposed U.S. indication positions saroglitazar as combination treatment with UDCA in adults with an inadequate response, or as monotherapy in patients unable to tolerate UDCA. This is a proposed indication, not an approved prescribing recommendation. PBC management consensus includes referral to a centre with specific clinical and research expertise in PBC. The expanded-access policy requires requests from the treating physician and does not guarantee access.
Heterogeneity of treatment effect
EPICS-III: subgroup defined by baseline ALP
| Subgroup or outcome | Quoted value |
|---|---|
| Baseline ALP threshold | “≤ 3 x ULN” |
| Saroglitazar biochemical response | “83.1%” |
| Placebo biochemical response | “14.7%” |
PPAR-agonist systematic review: between-study heterogeneity
Care management intervention strategies
Risk-stratified follow-up intervals
| Risk category | Quoted interval |
|---|---|
| Intermediate or high risk of disease progression: at least | “every 6 months” |
| Low risk of disease progression: at least | “once a year” |
Other product development or post-marketing obligations required by the FDA
Not applicable.
Ongoing post-approval monitoring
Not applicable.