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Dow development laboratories, llc is a company specialized in topical drug product manufacturing and formulation. We take pride in providing top-notch services for topical formulation design.
Dow development laboratories, llc is a company specialized in topical drug product manufacturing and formulation. We take pride in providing top-notch services for topical formulation design.
3D figure wearing a yellow hard hat stands next to a yellow diamond-shaped sign that reads "SAFETY FIRST," raising one hand as if to signal stop, emphasizing the importance of drug safety in clinical trials and topical drug applications.

Safety First: What’s Needed Before a Topical Drug Enters the Clinic

Non-clinical testing for IND submission:

Before a new topical drug product can enter clinical trials, the FDA requires specific non-clinical safety studies—even if the active pharmaceutical ingredient (API) has already been approved for use via another route, such as oral or injectable administration.

For topical formulations like creams, gels, ointments, or lotions, safety—not efficacy—is the priority at this preclinical stage. This means conducting a range of studies to evaluate local and systemic effects of dermal exposure. Typical IND-enabling studies for topicals include:

– Primary skin irritation
– Dermal sensitization
– Repeat-dose dermal toxicity (to assess cumulative effects)
– Systemic toxicity and toxicokinetics (particularly if systemic exposure is expected)

Even for well-characterized drugs, if the route of administration changes, the FDA considers the safety profile to be formulation-dependent. So, a new topical version will require its own set of non-clinical data to support first-in-human use.

The duration of the studies, number of daily applications, and total surface area treated are all factors that must align with the intended clinical protocol and the drug’s pharmacology. For example, a product intended for long-term, chronic use on large body areas will require longer-term dermal toxicity studies compared to a short-course facial application.

Before launching into non-clinical work, many sponsors find it valuable to request a Pre-IND meeting with the FDA. This interaction provides an opportunity to discuss the proposed non-clinical plan and get agency feedback on study design, species selection, and any unique product characteristics that could influence the development path. A well-aligned non-clinical strategy can help reduce delays later and support a smoother IND review.

References

  • FDA Guidance for Industry: Nonclinical Safety Evaluation of Drug or Biologic Combinations – https://www.fda.gov/media/72249/download
  • FDA Guidance: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization – https://www.fda.gov/media/71542/download
  • FDA Guidance: Nonprescription Sunscreen Drug Products — Safety and Effectiveness Data – https://www.fda.gov/media/120328/download
  • Pre-IND Consultation Program Overview – FDA – https://www.fda.gov/drugs/investigational-new-drug-ind-application/innovative-drug-development-pre-ind-consultation-program