New Oral Weight Loss Pills Coming Soon: The Next Generation of GLP-1s

The world of weight loss medication is currently dominated by injectables like Wegovy, Ozempic, and Zepbound. While these drugs have changed how we treat obesity, the requirement for weekly injections remains a barrier for many patients. This is about to change. Pharmaceutical giants including Eli Lilly and Pfizer are racing to develop oral versions of these powerful drugs. These new pills promise to offer similar weight loss results without the needles, potentially solving supply shortages and lowering costs.

Here is a detailed look at the oral weight loss pills currently in the pipeline and when you might expect to see them.

Eli Lilly’s Orforglipron: The Leading Contender

Eli Lilly, the manufacturer of Mounjaro and Zepbound (tirzepatide), is currently leading the race with an experimental drug called orforglipron. Unlike current injectable options which are peptide-based, orforglipron is a “small molecule” drug. This distinction is vital because small molecules are easier to manufacture and do not require the complex refrigeration that biologics need.

Clinical Trial Results

The data surrounding orforglipron is promising. In Phase 2 clinical trials published in the New England Journal of Medicine, participants taking the highest dose of the daily pill achieved an average weight loss of 14.7% over 36 weeks. This efficacy is approaching the results seen with injectable semaglutide (Wegovy).

Timeline for Availability

Eli Lilly is currently conducting Phase 3 clinical trials, which are the final stage before seeking FDA approval. These trials, known as the ATTAIN program, are expected to wrap up in 2025. If the data remains consistent, consumers could see orforglipron enter the market shortly thereafter.

Pfizer’s Danuglipron: A Pivot to Once-Daily Dosing

Pfizer has faced a more turbulent path in this sector but remains a key player. Their primary candidate is danuglipron. Originally, Pfizer tested a twice-daily version of this pill. While it was effective for weight loss, the twice-daily formulation caused high rates of gastrointestinal side effects, leading many trial participants to drop out.

The Strategy Shift

In late 2023, Pfizer announced it would discontinue the twice-daily version to focus entirely on a once-daily modified-release formulation. The company believes a once-daily pill will be better tolerated by patients and more competitive in the market.

Pfizer is currently generating data to determine the optimal dosage for this new formulation. They are expected to share widely anticipated data on the once-daily version in the second half of 2024. If successful, this drug could offer a potent alternative to injections, though it is likely slightly behind Eli Lilly’s timeline.

Other Emerging Competitors

While Pfizer and Eli Lilly capture the most headlines, smaller biotech firms and other major pharma companies are also making significant strides.

  • Viking Therapeutics (VK2735): Viking recently released Phase 1 data for an oral tablet version of their drug VK2735. In early trials, patients lost up to 3.3% of their body weight in just 28 days. This drug targets both GLP-1 and GIP receptors, similar to Zepbound.
  • Roche (CT-996): Following its acquisition of Carmot Therapeutics, Roche entered the race with CT-996. Phase 1 data released in mid-2024 showed a 6.1% weight loss over four weeks. This is an early-stage drug, so commercial availability is likely several years away.
  • Novo Nordisk (Amycretin): The maker of Ozempic is developing a new oral pill called amycretin. Early Phase 1 results showed participants lost 13.1% of their weight after 12 weeks. This is significantly higher than the 6% loss seen with their current oral drug, Rybelsus, over the same period.

Why Oral Pills Could Solve the Shortage Crisis

The current shortage of Wegovy and Zepbound is largely due to manufacturing bottlenecks. These drugs are peptides (complex chains of amino acids) and require specialized “fill-finish” manufacturing capacity to put the liquid into injection pens.

The shift to oral pills like orforglipron and danuglipron solves this problem in two ways:

  1. Chemical Synthesis: As small molecule drugs, they are produced through chemical synthesis rather than biological processes. This allows them to be mass-produced in factories much like aspirin or statins.
  2. No Injection Pens: Producing plastic injector pens is a major supply chain choke point. Pills require only standard bottling or blister packs.

Managing Expectations: Side Effects

It is important to note that switching from a needle to a pill does not eliminate side effects. The mechanism of action for these drugs involves slowing down gastric emptying and signaling satiety to the brain.

In trials for both Pfizer and Eli Lilly, gastrointestinal issues were the most common complaint. These included:

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation

Because the medication is processed through the digestive system, some patients may actually find the stomach-related side effects more pronounced with pills than with injections. However, titration (slowly increasing the dose over time) is used to mitigate this discomfort.

Frequently Asked Questions

When will the new Pfizer and Eli Lilly weight loss pills be available? Eli Lilly’s orforglipron could potentially be approved as early as late 2025 or 2026, pending successful Phase 3 trials. Pfizer’s timeline depends on the results of their new once-daily formulation trials occurring in 2024.

Are these pills as effective as Ozempic or Mounjaro? Current data suggests they are very close. Orforglipron showed nearly 15% weight loss, which is comparable to Wegovy but slightly less than Zepbound (which can reach over 20%). However, convenience may make them a preferred choice for many.

Will oral weight loss pills be cheaper? Ideally, yes. Small molecule drugs are significantly cheaper to manufacture than biologics. However, pharmaceutical pricing is complex. While production costs are lower, the market demand is high, so initial pricing may still remain premium until more competition enters the market.

Is there already an oral weight loss pill? Yes. Rybelsus (oral semaglutide) is currently available. However, it is primarily approved for Type 2 diabetes and requires strict administration rules (taken on an empty stomach with no more than 4 ounces of water). The newer pills aim to be more potent and have fewer dietary restrictions.