Transparency
We communicate clearly, consistently and responsibly, providing stakeholders with timely and balanced information on our progress, challenges and outcomes.
Paradigm Biopharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing differentiated therapies for diseases with significant unmet medical need.
Five stages take a proven molecule from a scientific hunch to a treatment in a patient's hands.
We look for molecules with real scientific rationale behind them and a disease with no good answer. Starting from a compound already proven safe in people means the question is efficacy, not whether it can be given to a patient at all.
Preclinical and early clinical work establishes whether the rationale survives contact with data. This is the stage that decides whether a programme is worth a late-stage trial, and the stage where a disciplined company says no.
Randomised, double-blind, placebo-controlled trials run to a pre-agreed endpoint. Our lead programme, PARA_OA_012, recruited 538 participants across 65 sites in four countries against a 466 target.
We are a development company, not a global sales force. Partnerships with organisations that already have manufacturing, regulatory and commercial reach are how a treatment gets from a positive result to a patient.
Paradigm’s commercialisation strategy is supported by an established pharmaceutical manufacturing and supply chain. iPPS can be manufactured at commercial scale through an established source with a proven regulatory track record, avoiding the need to develop an entirely new manufacturing process or supply network.
This provides a strong foundation for commercial readiness, with demonstrated scalability, manufacturing continuity and greater certainty of supply as the program progresses toward potential registration and launch.

Project Timeline
100% recruitment achieved and successful clinical trial readout.
Pre-IND meeting with US FDA and EMA Scientific Advice Meeting completed.
Clinical study PARA_OA_008 formally initiated.
Phase 2 meets primary endpoint; Fast track designation granted for Phase 3 program.
Completion of 12-month duration study with positive 6-month MRI data results.
Phase 3 protocol submitted and successfully cleared by the US FDA.
We communicate clearly, consistently and responsibly, providing stakeholders with timely and balanced information on our progress, challenges and outcomes.
We take responsibility for our decisions, commitments and performance, with a focus on disciplined execution and delivering against clearly defined objectives.
We work closely with clinicians, patients, research partners, regulators and manufacturing partners to advance our programs efficiently and responsibly.
We recognise the contribution of every patient, clinician and partner involved in our development programs, and place patient wellbeing and scientific integrity at the centre of our decisions.
We respond to emerging evidence, regulatory guidance and development learnings, adapting our approach where required to improve outcomes and reduce execution risk.
We apply scientific insight and disciplined development to identify new therapeutic potential in established molecules, with the aim of addressing significant unmet medical needs.
Corporate headquarters in Melbourne, and 65 Phase 3 sites delivered with CRO partners Advanced Clinical and NBCD A/S.
Deep expertise across the development lifecycle, from first evaluation to established supply.
Designing and running global trials to a pre-agreed endpoint. PARA_OA_012 recruited 538 participants across 65 sites in four countries.
Several regulators on one programme. FDA Fast Track designation was granted in 2022 for knee osteoarthritis.
Patient-reported outcomes paired with imaging and structural markers, so a result can be read in more than one way.
The compound is already produced at scale by established suppliers, so supply is a solved problem rather than the last hurdle.
Reworking how an established molecule is delivered so it can reach a new indication. The molecule is not new; the route and the target are.
Partners with existing manufacturing, regulatory and commercial reach are how a treatment gets from a positive result to a patient.
Working with established partners across development, manufacturing, regulatory strategy and translational research.