Developer · IL

NeuroDerm

Rehovot-based drug-device company (ND0612 continuous subcutaneous levodopa/carbidopa); wholly-owned subsidiary of Mitsubishi Tanabe Pharma since 2017.

1compound
1program
1indication
Filed (NDA)lead asset

Phase distribution

  • Filed (NDA)1

Modality

  • Small molecule 1

Mechanism focus

Pipeline (1)

Deals & partnerships

Catalysts · 0 upcoming · 2 reported

Recently reported

Recent activity

  • Mar 15, 2024ReadoutND0612 (levodopa/carbidopa continuous subcutaneous infusion)·Parkinson's diseasemetBouNDless full results published in Lancet Neurology (Espay et al. 2024;23(5):465-476): +1.72 h/day ON time without troublesome dyskinesia (95% CI 1.08-2.36, p<0.0001), OFF time -1.40 h/day; first four hierarchical secondary endpoints met; infusion-site reactions the most common adverse event.source ↗
  • Dec 31, 2023Phase changeND0612 (levodopa/carbidopa continuous subcutaneous infusion)·Parkinson's diseaseFiled (NDA)NDA submitted to the U.S. FDA during 2023. YEAR-PRECISION ANCHOR: no company release discloses the exact submission date — the FDA resubmission-acceptance announcement (2025-05-28) states only that the NDA 'was initially submitted to the FDA in 2023'. The 2023-12-31 date is a sortable year-end anchor, not a real date. The program has remained at 'filed' through two Complete Response Letters (announced 2024-06-11 and 2025-10-23; captured as events, not phase changes): the NDA is not withdrawn, a further resubmission is planned, and the EMA MAA (accepted 2025-02-20) is under active review.source ↗
  • Jan 9, 2023ReadoutND0612 (levodopa/carbidopa continuous subcutaneous infusion)·Parkinson's diseasemetBouNDless Phase 3 topline: ND0612 met the primary endpoint, delivering a clinically meaningful and statistically significant increase in ON time without troublesome dyskinesia vs optimized oral IR-LD/CD, and met the first secondary endpoints in the hierarchy.source ↗
  • Sep 30, 2019Phase changeND0612 (levodopa/carbidopa continuous subcutaneous infusion)·Parkinson's diseasePhase 3Pivotal Phase 3 BouNDless trial (NCT04006210, ND0612-317) started per ClinicalTrials.gov: multicenter, randomized, active-controlled, double-blind, double-dummy trial of continuous subcutaneous ND0612 vs oral IR-LD/CD in Parkinson's disease with motor fluctuations, at 117 sites in 16 countries.source ↗
  • May 4, 2016Phase changeND0612 (levodopa/carbidopa continuous subcutaneous infusion)·Parkinson's diseasePhase 2Phase 2b open-label long-term safety study BeyoND (NCT02726386, ND0612H-012) started per ClinicalTrials.gov (214 enrolled, international). Earlier Phase 1/2 PK studies preceded this (e.g. NCT02096601), and development at the time was split into higher-dose ND0612H and lower-dose ND0612L before consolidation into a single ND0612 program after FDA feedback; BeyoND's start is used as the phase_2 anchor because it is the earliest clean registry date for the program that fed the NDA.source ↗

Competitive landscape

Other companies developing against NeuroDerm's targets or indications.