LEVOKETOCONAZOLE - Generic Drug Details

What are the generic drug sources for levoketoconazole and what is the scope of patent protection?

Levoketoconazole is the generic ingredient in one branded drug marketed by Strongbridge and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Levoketoconazole has thirty-three patent family members in twenty-one countries.

One supplier is listed for this compound.

Summary for LEVOKETOCONAZOLE

International Patents:	33
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	6
Patent Applications:	2,929
What excipients (inactive ingredients) are in LEVOKETOCONAZOLE?	LEVOKETOCONAZOLE excipients list
DailyMed Link:	LEVOKETOCONAZOLE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LEVOKETOCONAZOLE

Constraining patent/regulatory exclusivity:

FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LEVOKETOCONAZOLE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cortendo AB	Phase 1
Cortendo AB	Phase 3

See all LEVOKETOCONAZOLE clinical trials

Pharmacology for LEVOKETOCONAZOLE

Drug Class	Cortisol Synthesis Inhibitor
Mechanism of Action	Cytochrome P450 11A1 Inhibitors Cytochrome P450 11B1 Inhibitors Cytochrome P450 17A1 Inhibitors Cytochrome P450 2B6 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LEVOKETOCONAZOLE

H02CA	Anticorticosteroids
H02C	ANTIADRENAL PREPARATIONS
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for LEVOKETOCONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes

International Patents for LEVOKETOCONAZOLE

Country	Patent Number	Title	Estimated Expiration
New Zealand	560481
European Patent Office	1853266	2S,4R KETOCONAZOLE POUR LE TRAITEMENT DU DIABETE, DU SYNDROME METABOLIQUE ET D'AUTRES CONDITIONS (2S,4R KETOCONAZOLE FOR TREATING DIABETES, METABOLIC SYNDROME AND OTHER CONDITIONS)
European Patent Office	1853266
South Korea	101387910
South Africa	200706020	Methods and compositions for treating diabetes, metabolic syndrome and other conditions

LEVOKETOCONAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Levoketoconazole (Recorlev®)

Introduction

Levoketoconazole, marketed as Recorlev®, is a significant player in the treatment of endogenous Cushing’s syndrome, a rare and life-threatening endocrine disorder. This article delves into the market dynamics and financial trajectory of this drug, highlighting its clinical efficacy, safety profile, and potential impact on the pharmaceutical market.

Clinical Efficacy and Safety Profile

SONICS and LOGICS Studies

The efficacy and safety of levoketoconazole have been extensively studied in the SONICS and LOGICS trials. The SONICS study, a phase 3, multicentre, open-label trial, demonstrated that levoketoconazole led to sustained improvements in urinary free cortisol (mUFC) levels with an acceptable safety and tolerability profile[5].

The LOGICS study, a phase 3, double-blind, placebo-controlled, randomized-withdrawal trial, further reinforced these findings, showing that withdrawing patients to placebo resulted in a significant loss of cortisol response, highlighting the therapeutic benefits of continued levoketoconazole treatment[2].

Post-Hoc Analysis Insights

A recent post-hoc analysis from the SONICS study presented at ENDO 2024 revealed that patients with lower baseline mUFC levels achieved higher cortisol normalization rates and required lower doses of levoketoconazole, resulting in fewer liver-related adverse events. This suggests a stratification strategy based on initial mUFC levels could enhance patient outcomes and reduce side effects[1].

Market Size and Growth

Adrenal Corticosteroid Inhibitors Market

The adrenal corticosteroid inhibitors market, which includes levoketoconazole, is projected to grow significantly. In 2023, the market size was estimated at USD 2.49 billion and is expected to reach USD 2.80 billion in 2024, with a compound annual growth rate (CAGR) of 12.75% to reach USD 5.78 billion by 2030[3].

Competitive Landscape

The market for Cushing’s syndrome treatments is evolving, with several drugs in development. However, levoketoconazole’s robust clinical data and favorable safety profile position it as a strong contender. The ongoing development of new drugs with improved efficacy and reduced side effects will continue to drive market growth[3].

Financial Trajectory

Revenue Potential

The positive clinical results from the SONICS and LOGICS studies are expected to enhance the marketability of Recorlev®, potentially leading to increased adoption by healthcare providers. This could drive revenue growth for Xeris Biopharma Holdings, Inc., the company behind Recorlev®. Improved efficacy and safety profiles can also bolster investor confidence, contributing to a healthier long-term revenue stream[1].

Regulatory Approval and Launch

Following the successful completion of the LOGICS study, Strongbridge Biopharma (now part of Xeris Biopharma) anticipated submitting a New Drug Application (NDA) to the FDA in the first quarter of 2021, with an expected launch in the first quarter of 2022. The successful regulatory approval and subsequent launch have been critical milestones in the financial trajectory of levoketoconazole[2].

Cost-Benefit Analysis

While the personalized treatment approach based on baseline mUFC levels can improve patient outcomes and reduce adverse events, it also involves increased monitoring costs. However, these costs can be offset by better patient outcomes, making the treatment more cost-effective in the long run. Investors should consider these factors in their overall cost-benefit analysis[1].

Real-World Application and Impact

Treatment Protocols and Guidelines

The findings from the clinical trials and post-hoc analyses could influence treatment protocols and guidelines for Cushing’s syndrome. An initial assessment of mUFC to tailor treatment plans could become a standard practice, leading to improved patient outcomes and a lower incidence of serious side effects[1].

Market Penetration

The unique selling proposition of Recorlev®, backed by robust clinical data, can help it gain significant market penetration. This is particularly important in a competitive market where other treatments for Cushing’s syndrome are available. The drug’s potential for expanded indications or usage in other cortisol-related disorders further enhances its market potential[1].

Key Takeaways

• Clinical Efficacy: Levoketoconazole has demonstrated sustained improvements in urinary free cortisol levels with an acceptable safety and tolerability profile.
• Market Growth: The adrenal corticosteroid inhibitors market is expected to grow significantly, driven by the increasing awareness and treatment of Cushing’s syndrome.
• Financial Trajectory: Positive clinical results and regulatory approvals are expected to drive revenue growth and bolster investor confidence for Xeris Biopharma Holdings, Inc.
• Personalized Treatment: Baseline mUFC levels can guide dosage and monitoring, potentially improving patient outcomes and reducing adverse events.
• Market Penetration: Robust clinical data supports the unique selling proposition of Recorlev®, enhancing its market potential.

FAQs

Q: What is the current market size of the adrenal corticosteroid inhibitors market?

The current market size of the adrenal corticosteroid inhibitors market was estimated at USD 2.49 billion in 2023 and is expected to reach USD 2.80 billion in 2024[3].

Q: What are the key findings from the SONICS and LOGICS studies on levoketoconazole?

The SONICS study showed sustained improvements in urinary free cortisol levels, while the LOGICS study demonstrated that withdrawing patients to placebo resulted in a significant loss of cortisol response, highlighting the therapeutic benefits of continued levoketoconazole treatment[2][5].

Q: How does the baseline mUFC level impact the treatment with levoketoconazole?

Patients with lower baseline mUFC levels achieved higher cortisol normalization rates, required lower doses of levoketoconazole, and experienced fewer liver-related adverse events[1].

Q: What is the expected growth rate of the adrenal corticosteroid inhibitors market?

The market is expected to grow at a CAGR of 12.75% to reach USD 5.78 billion by 2030[3].

Q: What are the potential financial benefits for Xeris Biopharma Holdings, Inc. from the success of Recorlev®?

The success of Recorlev® could drive revenue growth, bolster investor confidence, and potentially lead to expanded indications or usage in other cortisol-related disorders, enhancing the company’s long-term revenue stream[1][2].

Sources

1. Xeris Biopharma Holdings. Xeris Presents New Post Hoc Analysis on Effects of Levoketoconazole (Recorlev®) in Cushing’s Syndrome Patients at ENDO 2024. Stock Titan.
2. Strongbridge Biopharma plc. Strongbridge Biopharma plc Announces Positive and Statistically Significant Top-Line Results from the Pivotal Phase 3 LOGICS Study of RECORLEV (Levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome. Biospace.
3. 360iResearch. Adrenal Corticosteroid Inhibitors Market by Drug, Treatment Type. GIIR Research.
4. Xeris Pharmaceuticals. Xeris Biopharma Announces Results of the Extended Evaluation of Recorlev® (Levoketoconazole) From the Phase 3 Sonics Study Published in the European Journal of Endocrinology. Xeris Pharmaceuticals.
5. PubMed. A phase 3, multicentre, open-label, single-arm trial. PubMed.