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Last Updated: January 20, 2025

Investigational Drug Information for troriluzole


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What is the development status for investigational drug troriluzole?

troriluzole is an investigational drug.

There have been 8 clinical trials for troriluzole. The most recent clinical trial was a Phase 3 trial, which was initiated on January 29th 2021.

The most common disease conditions in clinical trials are Disease, Obsessive-Compulsive Disorder, and Compulsive Personality Disorder. The leading clinical trial sponsors are Biohaven Pharmaceuticals, Inc., Alzheimer's Disease Cooperative Study (ADCS), and Dana-Farber Cancer Institute.

There are two US patents protecting this investigational drug and thirty-three international patents.

Recent Clinical Trials for troriluzole
TitleSponsorPhase
Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain MetsBiohaven Pharmaceuticals, Inc.Phase 2
Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain MetsDana-Farber Cancer InstitutePhase 2
Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive DisorderBiohaven Pharmaceuticals, Inc.Phase 3

See all troriluzole clinical trials

Clinical Trial Summary for troriluzole

Top disease conditions for troriluzole
trials011223344DiseaseObsessive-Compulsive DisorderCompulsive Personality DisorderSpinocerebellar Degenerations[disabled in preview]
Top clinical trial sponsors for troriluzole
trials012345678Biohaven Pharmaceuticals, Inc.Alzheimer's Disease Cooperative Study (ADCS)Dana-Farber Cancer Institute[disabled in preview]

See all troriluzole clinical trials

US Patents for troriluzole

DrugnamePatent NumberPatent TitlePatent AssigneeEstimated Expiration
troriluzole ⤷  Subscribe Riluzole prodrugs and their use Biohaven Therapeutics Ltd. (New Haven, CT) ⤷  Subscribe
troriluzole ⤷  Subscribe Prodrugs of riluzole and their method of use Biohaven Therapeutics Ltd. (New Haven, CT) ⤷  Subscribe
>Drugname>Patent Number>Patent Title>Patent Assignee>Estimated Expiration
Showing 1 to 2 of 2 entries

International Patents for troriluzole

DrugnameCountryDocument NumberEstimated ExpirationRelated US Patent
troriluzole Australia AU2016226463 2035-03-03 ⤷  Subscribe
troriluzole Australia AU2020233650 2035-03-03 ⤷  Subscribe
troriluzole Australia AU2022202163 2035-03-03 ⤷  Subscribe
troriluzole Brazil BR112017018832 2035-03-03 ⤷  Subscribe
troriluzole Canada CA2978158 2035-03-03 ⤷  Subscribe
troriluzole China CN107567438 2035-03-03 ⤷  Subscribe
>Drugname>Country>Document Number>Estimated Expiration>Related US Patent
Showing 1 to 6 of 6 entries

Troriluzole: A Promising Drug Candidate for Spinocerebellar Ataxia

Introduction to Troriluzole

Troriluzole, a drug candidate developed by Biohaven, has been making significant strides in the treatment of spinocerebellar ataxia (SCA), a rare and debilitating neurodegenerative disorder. Here’s a comprehensive update on its development and market projections.

Background on Spinocerebellar Ataxia (SCA)

SCA is a group of genetic disorders that affect the cerebellum, leading to progressive loss of motor coordination and balance. It affects approximately 15,000 individuals in the U.S. and 24,000 in Europe and the U.K., with no FDA-approved treatments currently available[3].

Development History of Troriluzole

Troriluzole, a prodrug of riluzole, has faced several challenges in its development. Despite a phase 3 trial failure in 2022, Biohaven continued to pursue its potential, particularly after observing benefits in patients with type 3 SCA, the most common form of the disease. This persistence has led to promising new trial results[1].

Recent Clinical Trial Results

The latest clinical trials have shown that troriluzole significantly slows the progression of SCA. Patients treated with troriluzole exhibited a 50-70% slower rate of disease decline compared to untreated patients, translating to a delay in disease progression of 1.5 to 2.2 years over the course of the study[2][4].

Regulatory Status and Future Plans

Biohaven has submitted a New Drug Application (NDA) to the FDA for troriluzole in patients with SCA, following a pre-NDA meeting in the fourth quarter of 2024. The drug has received both Orphan Drug and Fast-Track designations from the FDA, making it eligible for Priority Review. Regulatory review is also underway in the EU[3][4].

Market Projections

If approved, troriluzole is projected to generate significant revenue. For 2025, it is estimated to generate $17 million in risk-adjusted revenue, accounting for about 56% of Biohaven’s total revenue. By 2035, troriluzole’s risk-adjusted revenues are expected to rise to $613 million, although its share of total revenue is estimated to fall to 13%[3].

Peak Revenue Potential

Analysts forecast substantial revenue potential for troriluzole, with peak revenues estimated at approximately $1.4 billion by 2040. This projection is based on the potential for a broad label covering all SCA genotypes and the significant unmet medical need in this area[5].

European Market Opportunity

The European market is seen as an additional upside for troriluzole, given the considerable patient population there. The current non-valuation of this market opportunity is expected to further boost the stock’s value[5].

Financial and Investor Outlook

Biohaven’s stock has seen a surge following the positive clinical trial results, reflecting investor optimism about the drug’s potential. The company’s strong cash position and diverse pipeline of drug candidates further support its growth prospects. However, investors must remain cautious about the risks associated with clinical trials and regulatory approval[2].

Additional Indications

Besides SCA, Biohaven is also testing troriluzole for obsessive-compulsive disorder (OCD), with interim and topline data from phase 3 trials expected soon. Analysts estimate potential risk-adjusted revenues of $18 million for troriluzole in OCD by 2026, with a probability of success of 47%[3].

Expert Insights

Tessa Romero, an analyst from J.P. Morgan, has maintained a Buy rating on Biohaven Ltd., citing the substantial opportunity for troriluzole in treating SCA and the company’s robust pipeline. Her associated price target is $68.00, reflecting the drug’s market potential and the company’s overall growth prospects[5].

Conclusion

Troriluzole represents a significant breakthrough in the treatment of spinocerebellar ataxia, a condition that has long lacked approved therapies. With its promising clinical trial results, strong regulatory support, and substantial market potential, troriluzole is poised to make a meaningful impact on the lives of SCA patients and the financial performance of Biohaven.

Key Takeaways

  • Clinical Trial Success: Troriluzole has shown a 50-70% slowing of SCA disease progression.
  • Regulatory Status: The drug has received Orphan Drug and Fast-Track designations and is eligible for Priority Review.
  • Market Projections: Estimated to generate $17 million in 2025 and $613 million by 2035.
  • European Market: Significant additional revenue potential from the European market.
  • Additional Indications: Being tested for OCD with promising interim data expected.

FAQs

Q: What is troriluzole and how does it work? A: Troriluzole is a prodrug of riluzole, designed to offer better bioavailability and dosing advantages. It works by slowing the progression of spinocerebellar ataxia.

Q: What were the results of the recent clinical trials for troriluzole? A: The trials showed a 50-70% slowing of disease progression in SCA patients, translating to a delay of 1.5 to 2.2 years over the study period.

Q: What is the current regulatory status of troriluzole? A: Biohaven has submitted an NDA to the FDA, and the drug has received Orphan Drug and Fast-Track designations, making it eligible for Priority Review.

Q: What are the market projections for troriluzole? A: It is estimated to generate $17 million in 2025 and $613 million by 2035, with peak revenues forecasted at $1.4 billion by 2040.

Q: Is troriluzole being tested for other conditions? A: Yes, it is also being tested for obsessive-compulsive disorder (OCD), with interim and topline data from phase 3 trials expected soon.

Sources

  1. Outsourcing-Pharma: "Biohaven's troriluzole shows promise in spinocerebellar ataxia"
  2. MarketBeat: "Biohaven Stock Soars on Drug Trial Results: Time to Jump In?"
  3. Visible Alpha: "Biohaven's Troriluzole Set to Break Ground in Neurological Disorder"
  4. PR Newswire: "Biohaven Achieves Positive Topline Results in Pivotal Study of Troriluzole in Spinocerebellar Ataxia (SCA)"
  5. Business Insider: "Strong Buy Rating for Biohaven Ltd. on Troriluzole's Market Potential and Robust Pipeline"

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