A Comprehensive Monograph on the Investigational HCV NS5A Inhibitor Odalasvir (DB13041)

Executive Summary

Odalasvir (DrugBank ID: DB13041) is an investigational small molecule antiviral agent that emerged as a highly potent, second-generation inhibitor of the Hepatitis C Virus (HCV) Nonstructural Protein 5A (NS5A). Developed initially by Achillion Pharmaceuticals and later in collaboration with Janssen, Odalasvir was engineered to overcome the limitations of first-generation NS5A inhibitors, demonstrating picomolar potency against a broad spectrum of HCV genotypes and, critically, retaining activity against common resistance-associated variants (RAVs).[1] Its pharmacological profile is characterized by a remarkably long terminal elimination half-life of approximately 250 hours, supporting a convenient once-daily dosing regimen.[2]

The clinical development program for Odalasvir focused on its use within a triple direct-acting antiviral (DAA) combination regimen, JNJ-4178, which also included the HCV NS5B polymerase inhibitor adafosbuvir (AL-335) and the NS3/4A protease inhibitor simeprevir. The cornerstone of its clinical evaluation, the Phase IIb OMEGA-1 trial (NCT02765490), yielded exceptional results. In a diverse population of patients with HCV genotypes 1, 2, 4, 5, or 6, the regimen achieved Sustained Virologic Response rates 12 weeks post-treatment (SVR12) of 98.9% with a 6-week course and 97.8% with an 8-week course.[3] These outcomes, achieved with remarkably short treatment durations, were accompanied by a favorable safety and tolerability profile, with most adverse events being mild and no treatment-related serious adverse events reported.[1]

Despite this profound scientific and clinical success, the development of Odalasvir was discontinued in September 2017.[4] This strategic decision by Janssen was not a reflection of any failure in the drug's efficacy or safety. Instead, it was a calculated response to the rapidly evolving and highly competitive commercial landscape for HCV therapeutics. By 2017, the market had become saturated with several highly effective, curative DAA regimens from competitors who had achieved first-to-market status, significantly diminishing the commercial viability for new entrants.[6] Consequently, Janssen pivoted its research and development focus to areas of higher unmet medical need, such as chronic Hepatitis B.[5][ The trajectory of Odalasvir thus serves as a compelling case study of a "successful failure"—a scientifically sound and clinically effective therapeutic candidate whose path to patients was ultimately foreclosed by market dynamics rather than by any intrinsic flaw.]

Chemical Profile and Physicochemical Characteristics

Identification and Nomenclature

[Odalasvir is a small molecule drug that has been systematically cataloged across major chemical and pharmacological databases under a consistent set of identifiers. This standardization is essential for accurate tracking throughout its research and development history.]

• Generic Name: Odalasvir [8]
• DrugBank Accession Number: DB13041 [8]
• CAS Number: 1415119-52-6 [8]
• Synonyms and External IDs: During its development, Odalasvir was referred to by several code names, which are critical for tracing its history through scientific literature and clinical trial registries. These include ACH-3102 and ACH-0143102 from its time at Achillion Pharmaceuticals, and JNJ-64289901 under Janssen's development program.[8] Other key identifiers for cross-database referencing include its Unique Ingredient Identifier (UNII) OVR52K7BDW and its ChEMBL ID CHEMBL3544977.[8]

Molecular Structure and Properties

[The chemical architecture of Odalasvir is complex and symmetrical, featuring a rigid central scaffold that is integral to its high-affinity binding to the NS5A target protein. This structure dictates its physicochemical properties, which in turn influence its behavior as a pharmaceutical agent.]

• Chemical Formula:  [8]
• Molecular Weight: The calculated average molecular weight is 1001.286 g·mol⁻¹, with a monoisotopic mass of 1000.55748207 Da.[8]
• Chemical Structure and Nomenclature: The formal IUPAC name for Odalasvir is methyl N--3-methylbutanoyl]-octahydro-1H-indol-2-yl]-1H-1,3-benzodiazol-6-yl}tricyclo[8.2.2.2$^{4,7}$]hexadeca-1(12),4(16),5,7(15),10,13-hexaen-5-yl)-1H-1,3-benzodiazol-2-yl]-octahydro-1H-indol-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate.[8] Its structure is characterized by two benzimidazole-octahydroindole ligands linked by a rigid [2.2]paracyclophane unit, a feature identified in structure-activity relationship studies as being superior for potency.[18][ For computational applications, its structure is represented by the following identifiers:]
• InChIKey: LSYBRGMTRKJATA-IVEWBXRVSA-N [8]
• SMILES:[ CC(C)C@@HNC(=O)OC]

[The physicochemical properties of Odalasvir, summarized in Table 1, are critical for understanding its pharmaceutical development challenges and pharmacokinetic profile. Its very low aqueous solubility and high lipophilicity (logP) are characteristic of many potent, complex molecules and necessitate careful formulation strategies to ensure adequate oral bioavailability. The molecule's large size and number of rotatable bonds contribute to its violation of Lipinski's "Rule of Five," a common set of guidelines for predicting drug-likeness, indicating that its absorption might not be straightforward.]

Table 1: Physicochemical Properties of Odalasvir

Property	Value	Source
Water Solubility	0.000969 mg/mL	ALOGPS
logP	7.68	ALOGPS
logP	11.17	Chemaxon
pKa (Strongest Acidic)	10.94	Chemaxon
pKa (Strongest Basic)	5.25	Chemaxon
Polar Surface Area	174.64 Ų	Chemaxon
Hydrogen Bond Acceptors	6	Chemaxon
Hydrogen Bond Donors	4	Chemaxon
Rotatable Bond Count	12	Chemaxon
Rule of Five Compliance	No	Chemaxon
Ghose Filter Compliance	No	Chemaxon
Veber's Rule Compliance	No	Chemaxon

Chemical Classification and Synthesis

[Odalasvir is classified as a small molecule belonging to the class of organic compounds known as valine and derivatives, reflecting the presence of two valine-derived moieties in its structure. Structurally, it is also defined by its fused-ring heterocyclic components, specifically the benzimidazole and octahydro-indole groups. From a therapeutic standpoint, it is categorized as an Anti-Infective and Antiviral Agent.]

[The path from a laboratory-scale synthesis to a robust, commercial-scale manufacturing process is a critical and resource-intensive phase of drug development. The significant investment in this area for Odalasvir underscores the seriousness of its development program prior to its discontinuation. Initial discovery efforts relied on a medicinal chemistry route that, while effective for producing small quantities, was inefficient for large-scale production. A dedicated process development program was undertaken to create a commercial route that improved throughput, reduced solvent and water usage, and dramatically lowered the process mass intensity (PMI) from 117.5 to 22.5. This optimized process proved robust and was successfully scaled up to produce batches of approximately 100 kg.]

[A pivotal achievement in this process development was the discovery and characterization of distinct solid-state forms of Odalasvir. While initial crystallization experiments often yielded an amorphous solid, further investigation identified a highly crystalline dihydrate, designated]

Form A[. This polymorph was found to be the most thermodynamically stable form and possessed advantageous properties for manufacturing, including higher purity, improved stability, and better handling characteristics compared to the amorphous material or other solvated forms (Form B and Form C). The ability to consistently produce a stable crystalline active pharmaceutical ingredient (API) is a cornerstone of modern pharmaceutical manufacturing, as it ensures predictable dissolution, bioavailability, and shelf-life. The successful development of a scalable synthesis for this superior crystalline form represented the overcoming of a major Chemistry, Manufacturing, and Controls (CMC) hurdle, signaling that the Odalasvir program was mature and on a clear trajectory toward regulatory submission and commercial launch from a manufacturing perspective.]

Preclinical and Clinical Pharmacology

Mechanism of Action

[Odalasvir exerts its potent antiviral effect by targeting a non-enzymatic viral protein that is nonetheless critical for the Hepatitis C virus life cycle. It is a direct-acting antiviral (DAA) that functions as a highly specific inhibitor of the HCV Nonstructural Protein 5A (NS5A). The NS5A protein is a large, hydrophilic phosphoprotein that plays a central, multifunctional role in viral propagation. Although it lacks enzymatic activity, NS5A is essential for two key stages of the viral life cycle:]

1. Viral RNA Replication:[ NS5A is a critical component of the viral "replication complex," a structure formed within modified host cell membranes (the "membranous web") where new copies of the viral RNA genome are synthesized.]
2. Virion Assembly and Secretion:[ NS5A is also intimately involved in the later stages of gathering viral components and assembling them into new, infectious virus particles that are subsequently released from the host cell.]

[By binding to the NS5A protein, Odalasvir is thought to disrupt its structure and function, thereby blocking both RNA synthesis and virion assembly, which effectively halts the viral life cycle. Additionally, NS5A has been implicated in the mechanisms by which HCV evades the host immune system, particularly in the development of resistance to interferon, which was a cornerstone of older, less effective HCV therapies.]

Comparative Pharmacology

The development of Odalasvir occurred within a rapidly advancing field of DAA discovery, and it was specifically designed as a second-generation[ NS5A inhibitor to improve upon the first-generation agents like daclatasvir and ledipasvir. Its key advantages lie in its enhanced potency, broader genotype coverage, and improved resistance profile.]

Compared to its predecessors, Odalasvir exhibits picomolar potency[ (indicating extremely high-affinity binding to its target) against a wide array of HCV genotypes, including 1a, 1b, 2, 4, 5, and 6, and retains potent nanomolar activity against genotype 3, which is often more difficult to treat.]

Perhaps its most significant pharmacological advantage is its robust activity against clinically relevant resistance-associated variants (RAVs)[. First-generation NS5A inhibitors have a relatively low genetic barrier to resistance, meaning that single amino acid substitutions in the NS5A protein can dramatically reduce their efficacy, leading to treatment failure. Odalasvir was specifically engineered to be less susceptible to these common RAVs, giving it a]

higher genetic barrier[ to the development of resistance. This characteristic made it a promising candidate for treating patients who had failed previous DAA therapies and for use in combination regimens designed to prevent the emergence of resistance in the first place.]

Pharmacokinetics (ADME)

[The study of a drug's absorption, distribution, metabolism, and excretion (ADME), or pharmacokinetics (PK), is fundamental to designing a safe and effective dosing regimen. Odalasvir's PK profile was evaluated in a series of Phase I clinical trials in healthy volunteers, including dedicated studies to assess its behavior in Japanese subjects.]

• Absorption and Distribution:[ Following oral administration, Odalasvir is absorbed into the systemic circulation. Its high lipophilicity suggests it would be widely distributed in tissues.]
• Metabolism and Excretion:[ The drug undergoes minimal metabolism. Its primary route of elimination from the body is through biliary secretion into the feces.]
• Half-Life:[ A defining feature of Odalasvir's pharmacokinetic profile is its exceptionally long terminal elimination half-life, which has been measured at approximately 250 hours. This very slow clearance from the body is a highly desirable attribute for a chronic therapy, as it ensures stable drug concentrations over a 24-hour period and strongly supports a convenient once-daily dosing schedule.]
• Transporter Interactions:[ Pharmacokinetic studies revealed that Odalasvir interacts with key drug transporter proteins. It is a substrate for the organic anion-transporting polypeptide 1B1 (OATP1B1), a transporter responsible for the uptake of drugs into liver cells. It also acts as an inhibitor of P-glycoprotein (P-gp), an efflux transporter that pumps substances out of cells. These interactions are mechanistically important, as they form the basis for several of the clinically observed drug-drug interactions.]

Drug-Drug and Drug-Vaccine Interactions

[The potential for a drug to interact with other medications is a critical safety and efficacy consideration. The interactions of Odalasvir were carefully studied, particularly with the other DAAs it was intended to be co-administered with. The results of these studies were not merely a safety concern to be managed but were a foundational element of the combination regimen's design. The pharmacokinetic synergy observed in Phase I trials, where the drugs mutually enhanced each other's concentrations, was a key factor in the high efficacy seen in later-stage trials. The doses used in the pivotal OMEGA-1 study were carefully selected based on the understanding of these interactions to achieve optimal exposure of all three antiviral agents. This deliberate leveraging of drug-drug interactions represents a sophisticated approach to combination therapy development. A summary of known and potential interactions is provided in Table 2.]

Table 2: Summary of Odalasvir Drug-Drug and Drug-Vaccine Interactions

Interacting Agent	Effect on Odalasvir PK	Effect of Odalasvir on Interacting Agent PK	Clinical Implication/Recommendation
Simeprevir (NS3/4A Inhibitor)	Area Under the Curve (AUC) increased 1.5- to 2-fold when co-administered.	AUC increased 1.5- to 2-fold when co-administered with Odalasvir.	Mutual pharmacokinetic enhancement. Doses in combination regimens were selected to account for this interaction.
Adafosbuvir (AL-335, NS5B Inhibitor)	AL-335 had no effect on Odalasvir PK.	AL-335 AUC increased 3-fold with Odalasvir alone and 7- to 8-fold with Odalasvir + Simeprevir.	Significant increase in adafosbuvir exposure, likely contributing to the high efficacy of the triple combination. This interaction is a key feature of the regimen.
Live Attenuated Vaccines (e.g., BCG, Rubella, Varicella)	Not applicable.	The therapeutic efficacy of live vaccines can be decreased.	This is a theoretical interaction based on the antiviral mechanism. Co-administration should be avoided as the antiviral may inhibit the replication of the vaccine virus, reducing the immune response.

Clinical Development and Efficacy Assessment

Overview of the Clinical Trial Program

[The clinical development of Odalasvir followed a logical and rigorous pathway, progressing from initial safety and dosing studies in healthy volunteers to larger, multicenter trials designed to establish its efficacy in patients with chronic HCV infection. The program reached a maximum clinical trial phase of II before its discontinuation. The primary indication investigated throughout its development was the treatment of Chronic Hepatitis C Virus (HCV) Infection. The program was initiated by Achillion Pharmaceuticals and was significantly advanced through a global collaboration with Janssen (and its subsidiary Alios BioPharma). The overall strategy focused on developing Odalasvir as part of an all-oral, interferon-free, short-duration combination therapy.]

Analysis of Key Clinical Trials

[The clinical efficacy and safety of Odalasvir-containing regimens were evaluated in a series of well-controlled studies. A summary of the most significant trials is presented in Table 3.]

Table 3: Summary of Key Clinical Trials for Odalasvir

Trial Identifier	Phase	Study Title/Objective	Regimen(s) Studied	Patient Population	Key Outcomes / SVR Rates	Status
NCT01700179	1	Safety, tolerability, and antiviral activity of ACH-0143102 plus ribavirin.	Odalasvir + Ribavirin	Treatment-naïve, HCV Genotype 1b	Established initial safety and antiviral activity.	Completed
NCT02512562	1	Evaluate the effect of Odalasvir and simeprevir on AL-335 pharmacokinetics.	Odalasvir + Simeprevir + AL-335	Healthy Volunteers	Characterized key drug-drug interactions that informed dosing for Phase II.	Completed
NCT02569710	2a	Safety, PK, and efficacy of AL-335 and Odalasvir, with or without simeprevir.	Odalasvir + AL-335 +/- Simeprevir	Treatment-naïve, HCV Genotypes 1, 2, or 3, with/without cirrhosis	Demonstrated high efficacy (100% SVR in some cohorts), guiding advancement to Phase IIb.	Completed
NCT02765490 (OMEGA-1)	2b	Efficacy, safety, and PK of AL-335, Odalasvir, and simeprevir.	Odalasvir (25mg) + AL-335 (800mg) + Simeprevir (75mg) for 6 or 8 weeks	Treatment-naïve & experienced, HCV Genotypes 1, 2, 4, 5, 6, without cirrhosis	SVR12: 98.9% (6-week arm), 97.8% (8-week arm).	Completed
NCT02993250	2	Safety, PK, and efficacy of AL-335, Odalasvir, and simeprevir in Japanese participants.	Odalasvir + AL-335 + Simeprevir	Treatment-naïve, HCV Genotypes 1 or 2, with/without cirrhosis	Confirmed safety and efficacy in a Japanese population.	Completed
NCT02821858	1	PK, safety, and tolerability of single ascending doses of Odalasvir and AL-335.	Odalasvir (single doses: 50mg, 100mg, 300mg)	Healthy Japanese Volunteers	Provided PK data to support development in Japanese populations.	Completed

Early Phase and Proof-of-Concept Studies

[Initial human trials, such as NCT01700179, paired Odalasvir (then known as ACH-0143102) with ribavirin in patients with genotype 1b HCV. These early studies were crucial for establishing the drug's safety profile in infected patients and providing the first evidence of its potent antiviral activity, paving the way for its inclusion in more complex DAA regimens. Subsequent Phase I studies in healthy volunteers (e.g., NCT02512562) were specifically designed to elucidate the complex pharmacokinetic interactions between Odalasvir, simeprevir, and AL-335, providing the data necessary to select the optimal doses for the combination.]

The OMEGA-1 Trial (NCT02765490)

[The OMEGA-1 study was the definitive trial of the Odalasvir-based regimen and the cornerstone of its late-stage development. This large, international, multicenter, randomized, open-label Phase IIb study was designed to robustly evaluate the efficacy and safety of the triple-DAA combination, JNJ-4178.]

• Design and Population:[ The trial enrolled 365 patients without cirrhosis who were either treatment-naïve or had previously failed interferon-based therapy. A key strength of the study was its inclusion of a broad range of HCV genotypes: 1a, 1b, 2, 4, 5, and 6. Patients with genotype 3 infection were excluded.]
• Treatment Regimen and Arms:[ All patients received a fixed-dose combination of Odalasvir 25 mg, AL-335 800 mg, and simeprevir 75 mg, administered orally once daily. They were randomized to one of two short-duration treatment arms: 6 weeks or 8 weeks.]
• Primary Endpoint and Results:[ The primary efficacy endpoint was the rate of Sustained Virologic Response 12 weeks after the completion of therapy (SVR12), which is considered the benchmark for a virological cure. The results were outstanding:]
• In the 6-week treatment arm, the SVR12 rate was 98.9%[ (181 out of 183 patients).]
• In the 8-week treatment arm, the SVR12 rate was 97.8%[ (178 out of 182 patients).]
• [Both treatment arms successfully met the pre-specified statistical endpoint of non-inferiority compared to a historical control rate of 98%. Virologic relapse after treatment was a rare event, occurring in only five patients (1.4%) across both arms of the study.]

Synthesis of Efficacy

[The collective data from the clinical development program, culminating in the OMEGA-1 trial, unequivocally established the Odalasvir-based triple regimen as a highly effective therapy for chronic HCV. The ability to achieve cure rates approaching 100% with a treatment course as short as six weeks was a remarkable scientific achievement. This level of efficacy, demonstrated across a wide range of viral genotypes and in both treatment-naïve and experienced patients, positioned the regimen to be a highly competitive therapeutic option, had it proceeded to market.]

Safety and Tolerability Profile

[A critical component of any successful therapeutic is a favorable balance between efficacy and safety. The clinical development program for Odalasvir consistently demonstrated that its high efficacy was accompanied by an excellent safety and tolerability profile. This was observed in Phase I studies with healthy volunteers and confirmed in the larger Phase II trials involving HCV-infected patients.]

• Adverse Events (AEs):[ Across the clinical program, the majority of reported adverse events were characterized as mild in severity. In the pivotal OMEGA-1 trial, the most commonly reported AEs were headache and fatigue, which are common, generally non-disruptive side effects seen with many DAA regimens. All randomized patients in this large study were able to complete their full course of treatment.]
• Serious Adverse Events (SAEs):[ A key finding from the OMEGA-1 trial was the absence of any treatment-related serious adverse events. An earlier, smaller Phase IIa study reported a single SAE of a cardiac conduction abnormality (Mobitz Type 1 atrioventricular block) that was attributed to treatment and resolved upon discontinuation; however, this signal was not replicated in the larger, more definitive Phase IIb study, suggesting it was not a common or dose-limiting toxicity.]
• Laboratory Findings:[ Clinical monitoring revealed no relevant or clinically significant laboratory abnormalities in patients receiving the Odalasvir-based regimen. This included stable liver function tests (alanine aminotransferase, total bilirubin) and hematological parameters like hemoglobin.]

[In summary, the safety data collected for Odalasvir and its combination regimen painted a picture of a well-tolerated therapy with a benign side-effect profile. This combination of near-universal efficacy and excellent safety represents the ideal target product profile for an antiviral drug, further underscoring that the program's termination was driven by external factors rather than any deficiency in the drug itself.]

Strategic Context and Discontinuation of Development

[The story of Odalasvir's development cannot be fully understood without examining the dynamic and intensely competitive commercial environment for Hepatitis C therapies in the mid-2010s. Its ultimate fate was determined not in the clinic, where it excelled, but in the boardroom, as a result of a strategic assessment of the market landscape.]

• Development and Partnership:[ Odalasvir was discovered and initially developed by Achillion Pharmaceuticals, a biotechnology company with expertise in antiviral drug design. Recognizing the potential of Achillion's HCV portfolio, Johnson & Johnson's pharmaceutical subsidiary, Janssen, entered into an exclusive worldwide license and collaboration agreement in May 2015. This partnership, valued at up to $905 million in potential milestones plus royalties, provided the financial and logistical resources to advance Odalasvir and other assets through late-stage global clinical trials.]
• The Decision to Discontinue:[ On September 11, 2017, Janssen announced its strategic decision to terminate the collaboration with Achillion and discontinue all further development of the investigational HCV regimen JNJ-4178 (containing Odalasvir, AL-335, and simeprevir). The company confirmed that ongoing Phase II studies would be completed as planned, but no new studies, including the pivotal Phase III trials required for regulatory approval, would be initiated.]
• Rationale for Discontinuation:[ The rationale provided by Janssen was explicit and transparent: the decision was made "in light of the increasing availability of a number of highly effective therapies addressing the medical need in hepatitis C". This was a purely commercial and strategic decision, not one based on any negative findings regarding the drug's efficacy or safety. The President and CEO of Achillion expressed disappointment, highlighting the regimen's demonstrated 100% cure rate after just six weeks of therapy in Phase IIa studies, but acknowledged Janssen's decision.]

[The period from 2013 to 2017 witnessed a paradigm shift in HCV treatment, arguably one of the most rapid and profound transformations in modern medicine. The introduction of the first all-oral, highly effective DAAs by companies like Gilead Sciences (sofosbuvir, ledipasvir/sofosbuvir) and later AbbVie (ombitasvir/paritaprevir/ritonavir and dasabuvir) revolutionized patient care. These therapies offered cure rates exceeding 95% with short, well-tolerated regimens, rendering older interferon-based treatments obsolete. By the time the Odalasvir regimen produced its excellent Phase IIb data in 2017, these competitors had already established a dominant market presence. They had not only captured significant market share but were also rapidly depleting the pool of eligible patients as more individuals were cured.]

[For Janssen, this created a challenging business case. The cost of conducting global Phase III trials, filing for regulatory approvals, and launching a new product into a crowded and shrinking market was substantial. The projected return on this massive investment was likely deemed insufficient, especially when compared to opportunities in other therapeutic areas. Consequently, Janssen made a calculated decision to reallocate its resources. The company announced it would pivot its infectious disease research and development efforts to focus on chronic Hepatitis B, a disease affecting over 250 million people globally for which there is no cure and thus a significant unmet medical need.]

[Odalasvir's journey thus serves as a powerful illustration of the concept of a "successful failure" in pharmaceutical development. The program succeeded on every scientific and clinical metric: it produced a potent, second-generation molecule; developed a robust manufacturing process; demonstrated exceptional cure rates in large clinical trials; and proved to be safe and well-tolerated. However, it was a "fast follower" in a race where the first few competitors to cross the finish line had effectively captured the entire prize. Its story is a critical lesson in pharmaceutical strategy, demonstrating that even a best-in-class scientific profile cannot guarantee commercial success in a hyper-competitive market that has been fundamentally transformed by preceding innovations.]

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