Cipla Launches Afrezza® in India: Revolutionizing Diabetes Care with Needle-Free Inhaled Insulin

With many diabetes mellitus (DM) patients struggling with the challenges of multiple daily insulin injections, there is a growing need for convenient and needle-free insulin delivery options. Addressing this gap, Cipla Ltd., one of India’s leading pharmaceutical companies, has recently launched a novel Technosphere® Insulin (TSI), the world’s only available inhaled insulin, under the brand name Afrezza^{® 1-4}.

Afrezza^® contains Technosphere® Insulin (TSI); is a dry powder formulation of regular human insulin adsorbed onto Technosphere® microparticles for oral inhalation. These microparticles are composed of key component fumaryl diketopiperazine (FDKP), with insulin bound to their surface. The TSI powder is administered through a breath-powered inhaler that ensures consistent and reproducible insulin delivery. Upon inhalation, the particles reach the lung alveoli, where the physiological pH (pH > 6) causes them to dissolve rapidly, allowing both insulin and FDKP to be quickly absorbed into systemic circulation ⁵.

Afrezza^®, available in 4U, 8U, and 12U cartridge strengths for flexible dosing based on individual insulin requirements, and indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza^® is prandial insulin and to be taken at the beginning of meal. It is contraindicated in patients with chronic lung disease and not recommended in active smokers, or who left smoking in recent 6 months. The Forced Expiratory Volume in 1 second (FEV1) assessment at the initiation of Afrezza^® therapy and its regular monitoring is recommended ⁶.

Afrezza^® has a rapid onset of action (~ 12 minutes), peak effect at ~45 minutes, with duration of ~180 minutes, offering “fast in, fast out” benefits and close resemblance to natural insulin ⁷.

Pivotal clinical trials have demonstrated the efficacy and safety of TSI in managing diabetes mellitus (DM) in adults. The landmark trials and key insights include:

Affinity 1: Technosphere® Insulin (TSI) Demonstrated Noninferiority to Insulin Aspart in Type 1 Diabetes Mellitus (T1DM) Patients ⁸

In a 24-week randomized non-inferiority trial comparing the efficacy and safety of TSI with insulin aspart in patients with T1DM and receiving basal insulin. TSI reduced HbA1c by 0.21% from a baseline of 7.94%, demonstrating non‑inferiority to insulin aspart, which reduced HbA1c by 0.40% from a baseline of 7.92%. The between‑group difference (0.19%; 95% CI: 0.02, 0.36) was within the predefined non‑inferiority margin of 0.4%. Additionally, TSI-treated patients experienced a lower rate of hypoglycaemia compared to those receiving insulin aspart [9.8 vs. 14.0 events/patient/month]. These findings highlight similar efficacy between TSI and insulin aspart, with the added advantage of a lower hypoglycemia event rate.

Affinity 2: Technosphere® Insulin (TSI) Provides significant HbA1c reduction in Type 2 Diabetes Mellitus (T2DM) patients ⁹

A 24-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of TSI Vs. Technosphere® placebo (TP) in insulin-naïve T2DM patients uncontrolled on oral antidiabetic drugs (OADs). TSI provided significantly higher HbA1c reduction Vs TP at 24 week (-0.8% vs -0.4%) with difference in HbA1c as -0.4%; 95% CI (-0.57, -0.23); P<0.0001. The TSI group demonstrated sustained post prandial glucose (PPG) reductions, resulting in a flatter and more stable prandial profile compared to TP. The incidence of all and severe hypoglycemia were higher in the TSI group than in the TP group [all hypoglycemia events/patient/month 1.16 vs 0.5, p value:<0.001; severe hypoglycemia events/100 patients/month 2.37 vs. 0.6, p value: 0.2024]. Mild, transient dry cough was the most common adverse event, reported in 23.7% (TSI) vs. 19.9% (TP).

Technosphere® Insulin (TSI) Demonstrated Significant HbA1c reduction in T2DM patients in Indian phase III study ¹⁰.

A 24-week, phase 3, randomized, double-blind, placebo-controlled, parallel-group study was designed to evaluate the efficacy and safety of TSI in Indian adults with T2DM inadequately controlled on oral antihyperglycemic drugs (OADs). A total of 216 patients (HbA1c 7.5-10.5%) were enrolled (TSI: n=133; Placebo: n=83). At week 12, TSI significantly reduced HbA1c Vs. Technosphere® placebo (TP) (-0.620% vs. -0.203%; mean difference -0.417%, 95% CI: -0.74, -0.09; P=0.0124). Hypoglycemia was reported as one of the most common adverse event [25.6% (TSI) vs. 16.9 % (TP)], with similar cough incidences in two groups [9% (TSI) vs. 8.4% (TP)]. The study also showed that TSI had no significant effect on lung function.

Now, ADA 2026 guidelines also recommended the use of inhaled insulin for prandial or correction doses in diabetes mellitus patients due to its faster onset and shorter duration than rapid-acting insulin analogues ¹¹.

Reference:

1. https://investors.mannkindcor p.com/news-releases/news release-details/mannkind corporation-announces-fda approval-afrezzar-novel-rapid; as accessed on February 2nd, 2026

2. https://investors.mannkindcor p.com/news-releases/news release-details/sanofi-and mannkind-announce-afrezzar only-inhaled-insulin-now; as accessed on February 2nd, 2026

3. https://www.cipla.com/press releases-statements/cipla launches-indias-only-inhaled insulin-afrezzar; as accessed on February 2nd, 2026

4. https://www.accessdata.fda.g ov/drugsatfda_docs/label/202 6/022472s027lbl.pdf; as accessed on February 2nd, 2026

5. Pfützner A, Forst T. Pulmonary insulin delivery by means of the Technosphere drug carrier mechanism. Expert Opin Drug Deliv. 2005;2(6):1097-106.

6. Afrezza India Prescribing Information. Available at https://www.ciplamed.com/product-index/afrezza?product-speciality=Diabetology. Accessed on 10^th december 2025.

7. Available from: https://afrezzahcp.com/mimics-physiologic-insulin/. Last accessed on.09th October 2025.

8. Bode BW, McGill JB, Lorber DL, Gross JL, Chang PC, Bregman DB, et al. Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial. Diabetes Care. 2015;38(12):2266-73.

9. Rosenstock J, Franco D, Korpachev V, Shumel B, Ma Y, Baughman R, et al. Inhaled Technosphere Insulin Versus Inhaled Technosphere® Placebo in Insulin-Naïve Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents. Diabetes Care. 2015;38(12):2274-81.

10. Poster # 833-P, ADA 2025, June 20-23, Chicago, IL.

11. ADA Professional Practice Committee for Diabetes*. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2026. Diabetes Care. 2026;49(Supplement_1):S183-S215.