New treatments take years of research, clinical trials, and regulatory review before reaching patients. Several therapies approaching FDA decisions this spring could expand treatment options for people managing a range of conditions.
CVS Caremark’s Clinical Pipeline Services team — made up of licensed clinical pharmacists and analysts — monitors new therapies moving through the drug pipeline and evaluates what those approvals could mean for members. The team’s latest Drugs to Watch report identifies several notable therapies with decisions expected between April and June 2026, including:
- A new oral option for patients with treatment-resistant hypertension
- A more convenient, at-home format for early Alzheimer's disease treatment that avoids lengthy IV infusions
- The first FDA-approved treatment for a chronic liver infection
- An additional non-nicotine option for adults looking to quit smoking
The following provides a closer look at each drug: what it is, why it matters, and how it could expand treatment options for patients.
Baxdrostat: a new mechanism for treating high blood pressure
Baxdrostat is an oral medication being reviewed for adults whose blood pressure remains uncontrolled despite treatment with multiple other blood pressure medications, a condition known as treatment-resistant hypertension. It would be used as an add-on to existing treatments. What makes Baxdrostat stand out is how it works: it inhibits aldosterone synthase (an enzyme involved in regulating blood pressure), an approach not currently available in approved treatments for this condition.
Treatment-resistant hypertension is blood pressure that stays above a target level even after trying at least three different medications at the right doses. A new mechanism may offer another way to control the condition, which could be significant for people who have run out of alternatives. If approved, it would be the first option of its kind for this population.
Status: Pending FDA approval 6/2/2026.
Leqembi Iqlik: an at-home treatment for Alzheimer’s
Leqembi Iqlik is an injectable form of Leqembi, a therapy already FDA-approved for the treatment of early Alzheimer’s disease. The existing version is given through an IV infusion every two weeks over an initial 18-month course. Leqembi Iqlik is already approved for ongoing treatment after that initial IV phase. If approved for this use, it would become the first therapy of its kind that patients could administer at home weekly from the start of treatment.
The shift to a weekly injection at home is what makes this approval worth watching. For patients and caregivers navigating early Alzheimer’s disease, reducing the burden of getting to a treatment facility could make a difference if and how people pursue this type of care.
Status: Pending FDA approval 5/24/2026.
Hepcludex: a possible first FDA-approved treatment for chronic hepatitis D virus infection in adults with chronic liver disease
Hepcludex (bulevirtide) is an injectable treatment being reviewed for chronic hepatitis D virus (HDV) infection in adults with chronic liver disease. If approved, it would be the first FDA-approved treatment for HDV, a condition with no FDA-approved treatment in the United States.
For patients living with a condition that has had no approved treatment, this could be a significant milestone. While taking Hepcludex on its own may allow some patients to eventually stop treatment, the data suggests combining it with another medication called pegylated interferon produces meaningfully better results — an important detail for providers and patients following this potential approval.
Status: Pending FDA approval 5/22/2026.
Cytisinicline: another tool in the fight to quit smoking
Cytisinicline is an oral therapy being reviewed for the treatment of nicotine dependence in adults seeking to quit smoking. It would join Varenicline (e.g., Chantix) and Bupropion as prescription options that don’t rely on nicotine replacement. If approved, it would be administered as part of either a six- or 12-week initial treatment course.
Quitting smoking is notoriously difficult, and one reason is that different approaches work for different people. More options increase the chances that patients can find an approach that works for them.
Status: Pending FDA approval 6/20/2026.
The bigger picture: what this spring’s pipeline says about where care is headed
The therapies expected this spring span different conditions and work in different ways. But each represents a meaningful step forward for patients who need care — whether that's a new option where existing treatments haven't worked, a first approval in a condition that has never had an approved treatment, or a more accessible way to take a therapy that already exists. For patients and providers alike, having more options means more room to find an approach that works.
Coverage will vary by plan, and not every approval will be relevant to every member. But staying informed about the pipeline is valuable. If any of these conditions affect you or someone you care for, it could be worth starting a conversation with your provider about what may be on the horizon.
CVS Caremark’s Clinical Pipeline Services team will continue tracking what is next so CVS clients and their plan members can stay informed as new therapies move closer to approval.
Learn more about the team and the Q2 2026 Pipeline Drugs to Watch Report.
