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Recent Clinical Updates: Otsuka & Sanofi
- Jana Chisholm
- 51 minutes ago
- 4 min read
We've had EyesOn recent clinical trial updates. Otsuka Pharma received approval for their ADHD therapy, Simtriyo, potentially a game changer for patients aged 6 and older. Meanwhile, Sanofi has stopped development of SAR445399, in bronchiectasis patients without cystic fibrosis as part of ther Portfolio re-alignment efforts.
Otsuka Pharmacutical - For patients six years of age and older with attention-deficit/hyperactivity disorder (ADHD), Otsuka Pharmaceutical’s once-daily extended-release capsule Simtriyo (centanafadine) has received FDA approval.
According to analysts, the approval of the first-in-class norepinephrine, dopamine, serotonin re-uptake inhibitor (NDSRI) provides the Japanese pharmaceutical company its next significant CNS launch and puts the treatment in a position to become a potential blockbuster in a sizable, under-penetrated market.
Simtriyo must pass the Drug Enforcement Administration’s (DEA) controlled-substance review process, which can take up to three months for all central nervous system stimulants, before it can be sold in the United States.
Simtriyo’s commercial potential may depend on how the DEA categorises it. According to the analysts, a lesser classification might provide Simtriyo a competitive edge in a congested ADHD market, while a schedule II categorisation similar to those of Adderall and Vyvanse could limit usage.
Otsuka stated in an April investor Q&A that it was unclear whether a DEA review would be required.
Simtriyo’s dopaminergic effects are probably why the FDA categorises it as a stimulant. Simtriyo increases the availability of certain neurotransmitters in attention and behavioural circuits by preventing their re-uptake.
According to the CDC, approximately 7 million children and 15.5 million people in the United States suffer from ADHD, a chronic neurodevelopmental condition marked by difficulties managing impulsive behaviours and paying attention.
The most common treatments for ADHD are stimulants, but patients frequently quit using them or switch between them because of their ineffectiveness, bothersome side effects, and shifting demands in their lives.
Therefore, rather than just gaining market share from already-existing drugs like Qelbree or Strattera, Otsuka sees the market as capable of sustaining numerous therapy classes and believes Simtriyo has an opportunity to expand the entire non-stimulant segment.
Otsuka has set a goal for Simtriyo peak sales of over $610 million based on the size of the market. The business acquired the medication from Neurovance in 2017 for $100 million up front and up to $150 million in possible development and regulatory milestone payments.
In four phase 3 clinical trials, Simtriyo demonstrated its value. When compared to a placebo, it significantly reduced ADHD symptoms as assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) in two adult studies and the ADHD Rating Scale-5 (ADHD-RS-5) in two paediatric trials.
The most frequent side effects in all four studies were rash and decreased appetite in children aged 6 to 12; decreased appetite, nausea, rash, headache, and abdominal pain in adolescents aged 13 to 17; and headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhoea in adults.
Simtryio also outperformed placebo on AISRS in patients with ADHD and concomitant anxiety, according to Otsuka’s favourable topline phase 3b results from a month ago.
Beyond Rexulti and Abilify Maintena, two atypical antipsychotics licensed to treat schizophrenia and other neurological conditions, the ADHD medication broadens Otsuka’s CNS product line. Less than a year ago, the FDA rejected Otsuka and partner Lundbeck’s Rexulti as a combination for post-traumatic stress disorder due to conflicting trial results,
According to analysts, Otsuka has access to a large prescriber base and a chance to capitalise on its well-established US commercial infrastructure because ADHD is largely treated in community settings.
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Sanofi - A phase 2 trial evaluating a monoclonal antibody, SAR445399, in bronchiectasis patients without cystic fibrosis was stopped by Sanofi.
The trial, which recently started in April, was a randomised, double-blind, placebo-controlled investigation to determine how much the mucus plug score decreased in adults with NCFB, a chronic lung condition, between the ages of 18 and 80 after receiving therapy with SAR445399 as opposed to a placebo. On July 29, the day before Sanofi’s second-quarter earnings call, the experiment was formally declared to have been suspended. The decision to halt the NCFB trial comes at a difficult time for Sanofi after a year of trial failures.
The anti-interleukin-1 receptor 3 monoclonal antibody SAR445399 was created to block the interleukin 1, 33, and 36 cytokine pathways; it was only made public by Sanofi in 2023. These pathways may play a part in respiratory disorders like NCFB and chronic immune-related dermatological diseases including hidradenitis suppurativa and atopic dermatitis.
According to Sanofi, the experiment was put on hold for strategic business reasons rather than safety concerns as part of a company-wide portfolio review. Paul Hudson, the previous CEO of the French pharmaceutical company, was fired in February, and Belén Garijo, M.D., Ph.D., the leader of Merck KGaA, was appointed to take over. Garijo has been working hard to rectify the company’s disorganised R&D and clinical initiatives ever since.
Despite its reputation as a $5 billion blockbuster, Sanofi discontinued amlitelimab for atopic dermatitis on July 24. Two more assets, balinatunfib and itepekimab, were also discontinued by the business during its second-quarter report due to unsuccessful trial outcomes in psoriasis and chronic obstructive pulmonary disease, respectively.
Approximately 500,000 Americans suffer from NCFB, and there are more than a million instances worldwide. Brinsupri, a DPP1 inhibitor that targets neutrophil activation, was approved by the FDA in August 2025 to treat NCFB in adults and children 12 years of age and older. Using their monoclonal antibody INFEX702, which works by inhibiting Pseudomonas aeruginosa, a bacterium considered to be a significant pathogen of NCFB, the British company Infex Therapeutics demonstrated encouraging NCFB phase 2a data.
SAR445399 is presently being tested in a different phase 2 study by Sanofi as a possible treatment for hidradenitis suppurativa, an inflammatory skin disorder.
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