pharma · Nonalcoholic Steatohepatitis (NASH) · Amyotrophic Lateral Sclerosis · CORT
CORCEPT THERAPEUTICS INC
Corcept Therapeutics is a pharma organization headquartered in Redwood City, USA. It trades on NYSE under ticker CORT. Primary therapeutic focus areas include Nonalcoholic Steatohepatitis (NASH), Amyotrophic Lateral Scle
Phase 3 · small molecule · Hypercortisolism
Relacorilant (LIFYORLI) is an oral small-molecule therapeutic developed by Corcept Therapeutics for the treatment of hypercortisolism. The program has completed Phase 3 clinical development and has received FDA approval, with the drug now marketed under the brand name LIFYORLI (copackaged formulation). Relacorilant rep
Internal code CORT125134-456
Relacorilant (LIFYORLI) is an oral small-molecule therapeutic developed by Corcept Therapeutics for the treatment of hypercortisolism. The program has completed Phase 3 clinical development and has received FDA approval, with the drug now marketed under the brand name LIFYORLI (copackaged formulation). Relacorilant represents Corcept's second approved treatment option in the hypercortisolism space, complementing the company's existing approved therapy mifepristone (Korlym). The drug was assigned NDA application number 220641 and has achieved regulatory authorization in the United States. As of September 2025, the program has reached its latest milestone, though specific details regarding the nature of this milestone are not yet disclosed. The approval of relacorilant expands the therapeutic arsenal available to patients with this rare endocrine disorder, offering an additional oral treatment option with a distinct mechanism from existing therapies.
Hypercortisolism, characterized by excessive cortisol production, represents a serious endocrine disorder with significant morbidity and mortality if left untreated. The condition can arise from various etiologies including adrenal tumors, pituitary adenomas, and ectopic ACTH secretion. Prior to the approval of relacorilant, treatment options were limited, making the expansion of the therapeutic landscape clinically significant. Relacorilant's approval provides physicians with an additional oral therapeutic option, potentially offering improved tolerability, efficacy, or convenience compared to existing treatments. The competitive landscape includes mifepristone (Korlym), also marketed by Corcept, as well as investigational agents such as FET (Disc Medicine, Phase 3) and SPI-62 (Lacuna Pharma, Phase 2). The approval of relacorilant strengthens Corcept's market position in hypercortisolism treatment and may capture market share from competitors entering this space. For patients, the availability of multiple oral treatment options enhances therapeutic choice and may improve outcomes through personalized treatment selection. The commercial significance is underscored by the rarity of hypercortisolism, which creates a specialized market with high treatment costs and strong reimbursement potential for approved therapies.
Drug Class: Glucocorticoid receptor antagonist (implied by indication and mechanism class)
Modality: Small-molecule oral therapeutic
Route of Administration: Oral
Brand Name: LIFYORLI (copackaged formulation)
Sponsor: Corcept Therapeutics Inc
Mechanism of Action: Not yet disclosed in available data
Target: Not yet disclosed in available data
Related Therapies: Mifepristone (Korlym), also marketed by Corcept Therapeutics, represents the primary approved comparator in the hypercortisolism space. Investigational competitors include FET (Disc Medicine) and SPI-62 (Lacuna Pharma).
First Approval: FDA approval confirmed via NDA 220641; approval date not yet disclosed
Patent Status: Not yet disclosed
Also known as: hypercortisolism, Cushing's syndrome, cortisol Excess, hyperadrenocorticism, pituitary basophilism, suprarenogenic syndrome
Cushing's syndrome (CS) encompasses a group of hormonal disorders caused by prolonged and high exposure levels to glucocorticoids that can be of either endogenous (adrenal cortex production) or exogenous (iatrogenic) origin.
ClinicalTrials.gov lists 48 registered studies for Cushing Syndrome (AACT aggregate).
Phase breakdown: NA (35), PHASE2 (7), PHASE3 (2), PHASE4 (2), PHASE1 (1), PHASE1/PHASE2 (1)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0018912), Orphanet — Cushing syndrome, NCT00001849, NCT00029952, NCT00081341, NCT00669266, NCT01382420, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Phase 3 enrollment and conduct
Phase 3 clinical trial (NCT04308590) conducted to support regulatory approval.
FDA approval
Relacorilant approved by FDA under NDA 220641 for hypercortisolism; specific approval date not yet disclosed.
Latest program milestone
Most recent milestone recorded; specific nature of milestone not yet disclosed.
Corcept Therapeutics maintains a dominant position in the hypercortisolism treatment market through its two approved therapies: mifepristone (Korlym) and the newly approved relacorilant (LIFYORLI). Both are small-molecule oral agents developed by Corcept, providing the company with significant competitive advantage and market control. Mifepristone, already established in the market, serves as the primary comparator for relacorilant. Emerging competition includes FET (Disc Medicine), currently in Phase 3 development, which represents a potential future threat to Corcept's market share. Additionally, SPI-62 (Lacuna Pharma) is in Phase 2 development for hypercortisolism related to benign adrenal tumors, targeting a specific patient subpopulation. The approval of relacorilant strengthens Corcept's competitive moat by providing physicians and patients with multiple oral options from a single sponsor, potentially enhancing patient retention and market penetration. However, the entry of FET into Phase 3 suggests competitive pressure may intensify in the coming years. Relacorilant's specific differentiation relative to mifepristone—whether through improved efficacy, safety, tolerability, or patient convenience—remains to be clarified in published clinical data.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| Mifepristone 300 MG [Korlym] | CORCEPT THERAPEUTICS INC | small_molecule | approved |
| FET | Disc Medicine | small_molecule | phase_3 |
| SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor | Lacuna Pharma Pty Ltd | other | phase_2 |
| OSILODROSTAT PHOSPHATE | — | Cytochrome P450 11B1 inhibitor | Approved |
| MIFEPRISTONE | — | Progesterone receptor antagonist | Approved |
| LEVOKETOCONAZOLE | — | Cytochrome P450 17A1 inhibitor | Approved |
| RELACORILANT | — | Glucocorticoid receptor antagonist | Phase 3 |
| PASIREOTIDE | — | Somatostatin receptor 1 agonist | Phase 3 |
| OSILODROSTAT | — | Cytochrome P450 11B1 inhibitor | Phase 3 |
| VORINOSTAT | — | Histone deacetylase 6 inhibitor | Phase 2 |
| TADALAFIL | — | Phosphodiesterase 5A inhibitor | Phase 2 |
| SELICICLIB | — | Cyclin-dependent kinase 2 inhibitor | Phase 2 |
| ROSIGLITAZONE MALEATE | — | Peroxisome proliferator-activated receptor gamma agonist | Phase 2 |
| ROSIGLITAZONE | — | Peroxisome proliferator-activated receptor gamma agonist | Phase 2 |
| PREDNISOLONE | — | Glucocorticoid receptor agonist | Phase 2 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
United States (FDA): Relacorilant has received FDA approval for hypercortisolism under NDA application number 220641. The drug is marketed under the brand name LIFYORLI in a copackaged formulation. Approval date is not yet disclosed in available data.
European Medicines Agency (EMA): Regulatory status in the European Union is not yet disclosed.
Pharmaceuticals and Medical Devices Agency (PMDA, Japan): Regulatory status in Japan is not yet disclosed.
National Medical Products Administration (NMPA, China): Regulatory status in China is not yet disclosed.
Approval History: Relacorilant represents Corcept's second approved hypercortisolism therapy, following the earlier approval of mifepristone (Korlym). The regulatory pathway and review timeline are not yet disclosed.
Relacorilant (LIFYORLI) is an FDA-approved oral small-molecule therapeutic indicated for the treatment of hypercortisolism, a condition characterized by excessive cortisol production.
Yes, relacorilant has received FDA approval under NDA application number 220641 and is marketed as LIFYORLI. The specific approval date is not yet disclosed.
Relacorilant is developed and marketed by Corcept Therapeutics Inc, a pharmaceutical company specializing in hypercortisolism treatments.
The specific mechanism of action of relacorilant is not yet disclosed in available data, though it is classified as a small-molecule oral therapeutic for hypercortisolism.
Relacorilant is marketed under the brand name LIFYORLI in a copackaged formulation.
Relacorilant is administered orally, making it a convenient treatment option for patients with hypercortisolism.
Relacorilant's approval was supported by Phase 3 clinical trial NCT04308590; however, detailed trial results and endpoints are not yet disclosed.
Competitors include mifepristone (Korlym, also by Corcept and approved), FET (Disc Medicine, Phase 3), and SPI-62 (Lacuna Pharma, Phase 2).
Regulatory status in the European Union, Japan, and China is not yet disclosed in available data.
The internal development code for relacorilant is CORT125134-456.
No development partner is disclosed; relacorilant is being developed solely by Corcept Therapeutics Inc.
Relacorilant has completed Phase 3 clinical development and has received FDA approval; it is now an approved marketed therapy.
Both are oral small-molecule therapies for hypercortisolism developed by Corcept; specific comparative efficacy and safety data are not yet disclosed.
Relacorilant was approved under FDA NDA application number 220641.
The first disclosure date for relacorilant is not yet disclosed in available data.
Projected peak sales figures for relacorilant are not yet disclosed in available data.
Relacorilant → Drug → Target → Indication → Company → Trials → Competitors
Strategic Positioning: Corcept's approval of relacorilant consolidates its market leadership in hypercortisolism treatment, creating a two-product portfolio that may enhance physician adoption and patient access. The copackaged formulation of LIFYORLI suggests potential combination therapy or convenience-based positioning.
Competitive Implications: The approval of relacorilant does not eliminate competitive threats from FET (Phase 3) and SPI-62 (Phase 2), but it establishes Corcept as the dominant player with multiple approved options. Competitors must differentiate on efficacy, safety, or patient convenience to gain market share.
Future Catalysts: Publication of Phase 3 clinical trial results for relacorilant will be critical for understanding its clinical profile relative to mifepristone and informing prescriber choice. Regulatory approvals in international markets (EMA, PMDA, NMPA) would expand market opportunity. Advancement of competing programs (FET Phase 3 completion, SPI-62 Phase 3 initiation) will intensify competition.
Expected Milestones: Clinical data publication, international regulatory submissions, and potential label expansions for specific patient subpopulations remain likely future catalysts. Peak sales projections and consensus analyst positioning are not yet disclosed.
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.