Romeg Therapeutics


ROMEG Therapeutics is a company focused on developing innovative drug formulations to better meet clinical and patient needs, targeting high unmet medical needs with novel therapies and expanding clinical indications. They aim to provide better treatment options for patients and physicians through their broad intellectual property portfolio and innovative products.

Industries

biopharma
manufacturing
medical

Nr. of Employees

small (1-50)

Romeg Therapeutics

400 TradeCenter, Suite 5900, Woburn, MA 01801


Patents

Methods and compositions for oral pilocarpine liquid

US-12409166-B2

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Methods and compositions for oral pilocarpine liquid

US-11564909-B2

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Products

Gloperba (colchicine oral solution)

An FDA-approved oral liquid colchicine formulation for prophylaxis of gout flares in adults; delivered as a flavored liquid intended to enable flexible/precision dosing and aid patients with pill-swallowing difficulties.

Pilocarpine oral solution (proprietary formulation)

Proprietary oral solution formulation of pilocarpine designed to provide an alternative to solid tablet dosing for patients with xerostomia, intended to improve ease of administration and palatability.

RMG-03 (investigational therapeutic candidate)

An investigational therapeutic candidate evaluated in an exploratory Phase 2 proof-of-concept study in patients with moderate COVID-19; study results were published in a peer-reviewed journal.


Services

Negotiation and agreement of exclusive licenses and commercialization arrangements to transfer marketing and distribution rights to partners.

Co-development collaborations that complement in-house expertise with external partners to advance early-stage reformulation and indication-expansion programs.

Expertise Areas

  • Formulation development and reformulation
  • Clinical trial design and execution (Phase 2 and early-stage)
  • Regulatory strategy for reformulated products (505(b)(2) pathways)
  • Intellectual property and patenting for formulations
  • Show More (3)

Key Technologies

  • Oral liquid formulation development
  • Dose-titratable/precision dosing formulations
  • Composition and method patenting
  • 505(b)(2) regulatory pathway
  • Show More (2)

News & Updates

On January 16, 2025, Scilex Holding Company amended its license agreement with Romeg Therapeutics for the rights to commercialize Gloperba, an FDA-approved prophylactic treatment for gout.

On August 29, 2024, the FDA approved the precision dosing label for GLOPERBA®, the first liquid formulation of colchicine for gout prophylaxis.


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