Dopamine Agonists Market: Competitive Landscape, Pipeline, and Market Analysis 2023

Dopamine Agonists are drugs that act upon Dopamine receptors located in the body, specifically in the brain, and activate them by mimicking the action of natural dopamine. Dopamine plays a dual role in our body by acting as a neurotransmitter as well as a neurohormone. It plays a role in body movements, memory, and pleasurable rewards and motivation. It is secreted during pleasurable situations, and therefore, dopamine is known to influence a  person’s mood and feelings. A disbalance of dopamine levels in the brain has been associated with many behavioral and mental disorders like Anxiety, Dementia, Parkinson’s disease (PD), and others. Conditions like Parkinson’s disease (PD) are characterized by low dopamine levels in the central nervous system. Hence, agonists are used to treat the symptoms of the disease and slow its progression. Research is being conducted globally to discover new and novel molecules to be used as dopamine agonists that may increase the level of dopamine in dopamine-deficient patients. The development and launch of new products will thus increase the market’s revenue in the forecasted years. According to the International Parkinson and Movement Disorder Society 2023 report, an estimated 9.4 million people globally are living with PD in 2020. According to the Parkinson’s Foundation 2023 report, nearly 1 million US residents have PD, while approximately 90,000 people are diagnosed yearly. The number of patients suffering from PD is expected to reach 1.2 million by 2030 in the USA. The prevalence of the disease has been rising continuously for many decades, which marks an opportunity for the market players.

A number of these inhibitors are in the market, while many are in ongoing clinical trials. 48 companies have various products in their pipelines, with 55 products in various stages of clinical trials. 9 products in Phase 4, 10 in Phase 3, 13 in Phase 2, and 9 in Phase 1 of the clinical trials.

Key Developments of Dopamine Agonists

• In August 2021, FDA approved Xywav (calcium/magnesium/potassium/sodium oxybates) along with Orphan drug designation for the treatment of adults with Idiopathic Hypersomnia (IH).
• In February 2021, FDA approved Gocovri (amantadine ER) as an adjuvant treatment to Levodopa/Carbidopa in Parkinson’s disease patients experiencing OFF episodes.
• In January 2021, European Commission (EU) granted Orphan drug designation to Xywav (calcium/magnesium/potassium/sodium oxybates) for the treatment of adults with Idiopathic Hypersomnia (IH).
• In July 2020, FDA approved Xywav (calcium/magnesium/potassium/sodium oxybates) for the treatment of people above 7 years with Cataplexy or Excessive Daytime Sleepiness associated with Narcolepsy.

Approved molecules of Dopamine Agonists

• Duodopa (levodopa/carbidopa intraduodenal gel infusion)
• Permax (pergolide)
• Cycloset (bromocriptine)
• Gocovri (amantadine ER)
• Xywav (calcium/magnesium/potassium/sodium oxybates)
• Akineton (biperiden)
• Kynmobi (apomorphine sublingual film)
• Osmolex ER (amantadine ER)
• Apofin (apomorphine)

Drugs in the Pipeline of Dopamine Agonists

• dexpramipexole (KNS-760704)
• Inbrija (levodopa inhalation powder)
• APO-go (apomorphine continuous subcutaneous infusion)
• levodopa/carbidopa high dose (ND0612H)
• Rytary (levodopa/carbidopa extended-release capsule)
• foscarbidopa/foslevodopa (ABBV-951)
• levodopa/carbidopa ER (WD-1603)
• Accordion Pill carbidopa/levodopa CR (carbidopa/levodopa CR)
• levodopa/carbidopa extended-release capsule (IPX203)
• apomorphine inhalational (VR 040)
• dopastatin (TBR-760)
• AM006
• Cerebral dopamine neurotrophic factor (CDNF)
• DopaFuse (levodopa/carbidopa continuous-release)
• Lecigon (carbidopa/levodopa/entacapone)
• Trivastal (piribedil)
• carbidopa ester transdermal (ND0611)
• levodopa prodrug (XP21279)
• levodopa/carbidopa low dose (ND0612L)
• Alcover (sodium oxybate)
• CLR4001
• Infudopa IntraV (levodopa/carbidopa IV)
• Infudopa SubC (levodopa/carbidopa SC)
• SER-214
• Sirio (carbidopa/melevodopa)
• XC130
• apomorphine intranasal
• deuterated sodium oxybate (JZP-386)
• fencamfamine prodrug (PRX-P4-003)
• levodopa/carbidopa CR (DM 1992)
• rotigotine microspheres (LY03009)

Clinical Activity and Developments of Dopamine Agonists

As of June 2023, 48 companies have approximately 55 products for 285 diseases. For these diseases, 104 trials are being conducted by players globally. For instance,

• In January 2023, Ain Shams University completed a Phase 4 clinical trial to study the impact of preoperative aripiprazole on postoperative analgesia in laparoscopic hysterectomy
• In September 2022, Luye Pharma Group Ltd completed a Phase 3 clinical trial to evaluate the effectiveness and safety of ly03003 in patients with early primary pd
• In May 2022, Otsuka Pharmaceutical Development & Commercialization, Inc. completed a Phase 4 clinical trial to assess the effects of engagement of flexible-dose Brexpiprazole as adjuvant therapy for treating adults with Major Depressive Disorders.